Background: Diabetic foot ulcers (DFUs) affect 9.1 to 26.1 million individuals globally each year, with 15-25% of those with diabetes mellitus (DM) experiencing them during their lives. DFUs are a major cause of amputations, accounting for 85% of such cases in diabetic patients. Curcumin, a compound from Curcuma longa, shows potential in wound healing through mechanisms such as inhibiting the NLRP3 inflammasome pathway, promoting autophagy, and regulating microRNA expression. This study evaluated the efficacy and safety of C3-DiagardTM Cream in treating DFUs. Methods: This open-label, prospective clinical study assessed the efficacy and safety of C3-DiagardTM cream, containing 0.05mg of Harida (Curcuma longa) extract, in treating and preventing DFUs. The cream was applied twice daily for 12 weeks. Key outcomes were assessed through wound size reduction, pain (VAS score), and any adverse reactions during the treatment. Results: Fifty DM patients (36 males, 14 females; mean age 57.58±12.67 years) were enrolled. Among the patients, 75% (38 individuals) showed a wound healing response between 70% and 99%. The average wound size decreased significantly from 6.63 cm2 at baseline to 1.83 cm2 after 12 weeks, with a mean reduction of 4.8 cm2 (p < 0.05). Pain levels, measured by VAS score, significantly dropped from an average of 8 to 3 (p < 0.05). No adverse reactions were reported, highlighting the cream’s safety. Conclusion: C3-DiagardTM cream is effective in reducing the size of diabetic foot ulcers and alleviating pain, with a favourable safety profile. This study supports the clinical use of C3-DiagardTM as a well-tolerated treatment option for patients with DFUs.
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Diabetic Foot Ulcer, Curcumin, Wound Healing, Curcuma Longa
1. Introduction
The global annual incidence of diabetic foot ulcers (DFUs) ranges between 9.1 to 26.1 million cases. Approximately 15 to 25% of individuals with diabetes mellitus (DM) experience the development of DFU at some point in their lives. This complication holds significant clinical importance as it stands as a primary cause of amputations in diabetic patients, with 85% of amputations being directly associated with DFUs.
The impact of DFUs extends beyond the immediate physical consequences, affecting both the quality of life and life expectancy of affected individuals. Notably, DFU patients face a 2.5-fold higher risk of mortality at 5 years compared to diabetes patients who do not develop foot ulcers
[1]
Sun X, Li R, Yang X, Yuan L. Efficacy and safety of topical oxygen therapy for diabetic foot ulcers: An updated systematic review and meta-analysis. Int Wound J [Internet]. 2022 May 5 [cited 2023 Dec 4]; 19(8): 2200–9. Available from:
. DFUs represent a prevalent complication in individuals with poorly controlled DM. The development of these ulcers is often attributed to factors such as inadequate glycemic control, underlying neuropathy, peripheral vascular disease, and suboptimal foot care, all of which contribute to the increased risk of complications such as osteomyelitis and lower extremity amputations. The occurrence of DFUs is frequently localized to areas of the foot subjected to repetitive trauma and pressure sensations. The progression of a diabetic ulcer typically unfolds in three stages—initially, a callus forms, a consequence of neuropathy. Motor neuropathy induces physical deformities in the foot, while sensory neuropathy results in a loss of sensation, leading to ongoing trauma. Additionally, autonomic neuropathy contributes to skin dryness. Subsequently, the callus undergoes frequent trauma, leading to subcutaneous hemorrhage. Eventually, the callus erodes, transforming into an ulcer. It is crucial to address the underlying factors contributing to the development of DFUs, including optimizing glycemic control, managing neuropathy, and promoting proper foot care practices. Early intervention and comprehensive care can mitigate the risk of complications, including osteomyelitis and the need for lower extremity amputations
[2]
Oliver TI, Mutluoglu M. Diabetic Foot Ulcer. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 [cited 2023 Dec 1]. Available from:
This underscores the severity of DFUs as a critical medical concern, emphasizing the need for effective prevention, early detection, and comprehensive management strategies to improve outcomes for individuals with diabetes
[1]
Sun X, Li R, Yang X, Yuan L. Efficacy and safety of topical oxygen therapy for diabetic foot ulcers: An updated systematic review and meta-analysis. Int Wound J [Internet]. 2022 May 5 [cited 2023 Dec 4]; 19(8): 2200–9. Available from:
. The incidence of DFUs is expected to rise annually alongside the increasing number of newly diagnosed diabetics. The etiology of DFUs is diverse, involving multiple factors. Common underlying causes include inadequate glycemic control, the presence of calluses, foot deformities, improper foot care, ill-fitting footwear, peripheral neuropathy, compromised circulation, dry skin, among others.
Neuropathy, a common complication affecting approximately 60% of individuals with diabetes, is a significant precursor to the development of foot ulcers. The risk of foot ulcers is further heightened in individuals with flat feet, as this anatomical condition leads to disproportionate stress across the foot, resulting in tissue inflammation in high-risk areas. Early identification and optimal treatment of foot ulcers play a crucial role in determining prognosis. Unfortunately, delays in care can have severe consequences, potentially culminating in the need for foot amputation.
The progression of DFUs is multifaceted, involving factors such as diabetic peripheral arterial disease, peripheral neuropathy, and foot malformations. The treatment of DFUs primarily focuses on symptomatic management, encompassing debridement, appropriate antibiotic therapy, and strategies to promote wound healing. However, the therapeutic outcomes are often suboptimal, and the prognosis remains a significant clinical challenge.
Given the limitations in current treatments, there is an urgent need to explore and develop drugs to address the complexities of DFUs. It is noteworthy that a majority (60–80%) of foot ulcers do heal with proper management. However, 10–15% of ulcers may persist, and 5–24% can progress to the point of requiring limb amputation within 6–18 months after the initial evaluation. This underscores the critical importance of early intervention and the ongoing quest for more effective therapeutic options to improve outcomes for individuals with DFUs
[3]
Alexiadou K, Doupis J. Management of Diabetic Foot Ulcers. Diabetes Ther [Internet]. 2012 Dec [cited 2023 Dec 1]; 3(1): 4. Available from:
Curcumin, derived from the rhizome of Curcuma longa, is an antioxidant polyphenol known for its anti-inflammatory properties. Numerous studies have documented the topical application of curcumin as a practice for promoting wound healing
[4]
Mokhtari M, Razzaghi R, Momen-Heravi M. The effects of curcumin intake on wound healing and metabolic status in patients with diabetic foot ulcer: A randomized, double-blind, placebo-controlled trial. Phytotherapy Research [Internet]. 2021 Apr [cited 2023 Dec 4]; 35(4): 2099–107. Available from:
. Curcumin, a polyphenol derived from Curcuma longa, commonly known as turmeric, and belonging to the ginger family, is characterized by its rhizomes that produce a vibrant yellow dye. The vital bioactive constituents of turmeric are phenolic curcuminoids, with curcumin (diferuloylmethane) being the most significant. In various wound models, curcumin has demonstrated the ability to reduce the secretion of cytokines, thereby promoting wound healing. Additionally, it serves as an effective antioxidant and radioprotective agent. Notably, curcumin has been shown to inhibit tumor necrosis factor (TNF) by diminishing its effects in fibroblast lytic assays. The anti-inflammatory properties of curcumin are attributed to its capacity for free radical scavenging activity
[5]
Jayaprasad K, Ramu J, Iyer S, C R K, Pattatheyil A. Open Labelled Pilot Study of Topically Applied Curcumin Versus Standard Treatment on Chronic Wound Healing. IJCMR [Internet]. 2018 Oct [cited 2023 Dec 4]; 5(10). Available from:
Curcumin exerts diverse biological activities through its interactions with various molecules and cellular targets. It regulates gene expression by influencing epigenetic modifications, including DNA methylation, histone modification, and microRNA expression. This multifaceted regulation affects numerous pathways and contributes to the wide range of biological effects attributed to curcumin. In the context of diabetic nephropathy, curcumin has demonstrated efficacy by inhibiting the NLRP3 inflammasome pathway. Additionally, curcumin promotes autophagy, mitigating renal tubular epithelial cell apoptosis induced by advanced glycation end products. Studies have revealed that curcumin's pharmacological actions include the inhibition of miR-133b, leading to the restoration of estimated glomerular filtration rate and acceleration of wound healing impaired by diabetes. Similarly, curcumin has been shown to decrease the expression of miR-138, contributing to enhanced wound healing. Additionally, the suppression of miR-152-3p has been associated with the inhibition of apoptosis promotion of fibroblast proliferation and migration, ultimately expediting the wound healing process in DFUs
[6]
Cao M, Duan Z, Wang X, Gong P, Zhang L, Ruan B. Curcumin Promotes Diabetic Foot Ulcer Wound Healing by Inhibiting miR-152-3p and Activating the FBN1/TGF-β Pathway. Mol Biotechnol [Internet]. 2024 Jan 11 [cited 2024 Jan 12]; Available from:
. The current study aimed to assess the efficacy and safety of C3-DiagardTM Cream in the treatment of DFUs.
2. Methodology
2.1. Study Design
This study is an open-label prospective clinical study designed to evaluate the efficacy and safety of C3-DiagardTM cream in the treatment and prevention of DFUs. The study protocol was approved by Suraksha Ethics Committee (Mumbai). All patients gave informed consent including for photographs of their wounds.
2.2. Study Drug
During the study, the enrolled patients were treated with a product that contained Harida (Curcuma longa) extract 0.05 mg. The cream was applied 1 cc per 5 cm2 ulcer size twice daily for 3 months.
2.3. Participants
The inclusion criteria encompassed both male and female individuals aged 20 to 80 years, inclusive, diagnosed with either Type 1 or Type 2 diabetes and undergoing therapy for glycemic control utilizing available diabetes drugs, including insulin. Participants having a glycosylated hemoglobin (HbA1c) ≤ 12%. Additionally, they needed to exhibit at least one DFU meeting specific criteria: a full-thickness ulcer of UTWCS Grade I-A or II-A, ulcer size (area) > 2 cm 2 and ≤ 10 cm2 post-debridement at the time of enrolment, the ulcer located on or below the malleoli, the ulcer present for > 4 weeks at the time of enrolment, and a minimum 3 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot post-debridement. Furthermore, participants must not have had an active infection by clinical inspection, as defined by IDSA/IWGDF criteria.
Exclusion criteria comprised pregnant or lactating women, individuals with a body mass index (BMI) exceeding 35 kg/m2, wounds requiring imminent surgical intervention (including revascularization or plastic surgery), and the presence of any clinically significant medical condition (s) in the medical history during the screening period that, according to the investigator's opinion, could interfere with wound healing. Patients currently receiving or scheduled to receive specific medications or therapies within 30 days of the enrollment visit, which could potentially interfere with wound healing during the study, were also excluded. Ulcers with exposed bone or associated with osteomyelitis, the presence of necrosis, purulence, or sinus tracts that could not be removed by debridement, as well as current sepsis, were additional exclusion criteria.
2.4. Outcome Measures
The primary outcome was the percentage of wound contraction using the Walker and Mason formula. Linear wound healing, which calculates the average distance the wound has healed from the initial wound edge to the centre of the wound, incidence of complete healing of the target ulcer measured to ensure the target ulcer area, such as length, width, and depth changed. The secondary outcome included visual analogue scale (VAS) score for pain, Treatment-Emergent Adverse Event (TEAE).
2.5. Statistical Analysis
The biostatistician analyzed the data using a finalized statistical analysis plan (SAP). All statistical analyses were performed using R Software. Data were summarized using descriptive statistics for continuous endpoints, including the number of subjects, mean, standard deviation, minimum, median, and maximum, while categorical endpoints were summarized with frequency and percentage. In this study, the changeover at different time points were compared using paired t test.
3. Results
The present study encompassed 50 patients diagnosed with DM, comprising of 36 males and 14 females. The mean age of the patients was 57.58±12.67 years. The majority (37.5%) of patients were taking metformin and insulin injections. All patients consistently applied C3-DiagardTM cream over the entire 12-week treatment duration.
In relation to the wound healing percentage, 75% (38) of patients exhibited a range of responses ranging from 70% to 99% (Figure 1). The average wound size at the start of the treatment was 6.63 cm, and 1.83 cm at the end of the treatment with a mean wound size reduction of 4.8 cm (p < 0.05) (Figure 2). There was significant reduction in the average VAS score for pain from 8 to 3 (p < 0.05) (Figure 3).
Figure 5. 54-year-old female patient with initial wound size of 5cm on day 0 experienced 95% wound healing at end of treatment.
4. Discussion
The development of DFUs is a prevalent complication among individuals with diabetes, affecting approximately 25% of them over their lifetime
[7]
Hicks CW, Selvin E. Epidemiology of Peripheral Neuropathy and Lower Extremity Disease in Diabetes. Curr Diab Rep [Internet]. 2019 Aug 27 [cited 2024 Jan 18]; 19(10): 86. Available from:
. These ulcers can lead to severe complications, including infections, amputations, and reduced quality of life
[8]
Chatterjee N, Ekka NM, Mahajan M, Kumar B, Kumar N, Zia A, et al. Effectiveness of Topical Sucralfate in the Management of Diabetic Foot Ulcers: An Open-Labeled Randomized Study. Cureus [Internet]. 2023 Apr 14 [cited 2024 Jan 11]; 15(4). Available from:
. C3-DiagardTM cream has been proposed as a treatment for DFUs due to its ability to promote wound healing and reduce inflammation. The study by Jiang et al. reflected that in diabetic patients with foot wounds, strict blood sugar control reduces the chance of amputation
[9]
Jiang P, Li Q, Luo Y, Luo F, Che Q, Lu Z, et al. Current status and progress in research on dressing management for diabetic foot ulcer. Front Endocrinol (Lausanne) [Internet]. 2023 Aug 17 [cited 2024 Jan 19]; 14: 1221705. Available from:
. Peripheral vascular disease and reduced blood flow further exacerbate the status of DFUs. The current approach to managing DFUs involves a comprehensive strategy encompassing blood sugar control, infection eradication, promotion of ulcer healing, and relief of high pressure. C3-DiagardTM cream has been suggested as a potential treatment for DFUs due to its wound healing and anti-inflammatory properties.
The demographic profile of our study reflects participants with an average age ranging from 50 to 60 years, with a gender distribution of 70% males and 30% females (36 males and 14 females). In a trial conducted by Agharazi et al., application of curcumin ointment lead to a significant reduction in the size of diabetic ulcers at five weeks
[10]
Agharazi M, Gazerani S, Huntington MK. Topical Turmeric Ointment in the Treatment of Diabetic Foot Ulcers: A Randomized, Placebo-Controlled Study. Int J Low Extrem Wounds. 2022 Dec 13; 15347346221143222.
[10]
. The findings of our study are similar to those of previous studies, which confirmed the safety and efficacy of C3-DiagardTM cream, formulated with harida extract, in promoting the healing of DFUs. The cream contributed to wound healing by reducing the average wound size by 4.8 cm, oxidative stress, suppressing inflammatory activities, and facilitating the proliferation and remodelling stages. The average VAS score for pain also reduced from 8 to 3. Notably, curcumin, a key component of C3-DiagardTM, has been associated with fibroblast infiltration into the wound site, accelerating the overall process of wound healing
[11]
Kumari A, Raina N, Wahi A, Goh KW, Sharma P, Nagpal R, et al. Wound-Healing Effects of Curcumin and Its Nanoformulations: A Comprehensive Review. Pharmaceutics [Internet]. 2022 Oct 25 [cited 2024 Jan 18]; 14(11): 2288. Available from:
. Moreover, our observations revealed that more than 90% healing was achieved for 23 (46%) patients in our study, with noticeable changes in the length, width, and depth of the ulcers. No major side effects were reported. C3-DiagardTM cream demonstrated good tolerability in all patients.
Despite its single-center focus and smaller sample size, the study holds valuable insights, providing a focused and detailed examination of the intervention's effectiveness. While acknowledging these limitations, the findings contribute significantly to the understanding of the targeted population, offering a foundation for future research and potential applications in similar settings.
5. Conclusion
Use of C3-DiagardTM cream led to a significant reduction in the size of diabetic ulcers and reduced pain. This study concludes that C3-DiagardTM is clinically effective in the management of diabetic foot ulcer. The absence of adverse reactions underscores the safety profile of C3-DiagardTM cream, making it a well-tolerated option for patients with diabetic ulcers.
Abbreviations
DFU
Diabetic Foot Ulcers
DM
Diabetes Mellitus
HbA1c
Glycosylated Hemoglobin
SAP
Statistical Analysis Plan
TEAE
Treatment-Emergent Adverse Event
TNF
Tumor Necrosis Factor
VAS
Visual Analogue Scale
Acknowledgments
We thank IntelliMed Healthcare Solutions Pvt Ltd. for data analysis and medical writing support.
Author Contributions
Milind Ruke: Conceptualization, Data curation, Investigation, Project administration, Supervision, Writing – original draft, Writing – review & editing
Iffat: Data curation, Investigation, Writing – review & editing
Arun Maurya: Data curation, Investigation, Writing – review & editing
The product is developed, and the study was funded by Stabicon Life Sciences Pvt. Ltd.
Conflicts of Interest
The authors declare no conflicts of interest.
References
[1]
Sun X, Li R, Yang X, Yuan L. Efficacy and safety of topical oxygen therapy for diabetic foot ulcers: An updated systematic review and meta-analysis. Int Wound J [Internet]. 2022 May 5 [cited 2023 Dec 4]; 19(8): 2200–9. Available from:
Oliver TI, Mutluoglu M. Diabetic Foot Ulcer. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 [cited 2023 Dec 1]. Available from:
Mokhtari M, Razzaghi R, Momen-Heravi M. The effects of curcumin intake on wound healing and metabolic status in patients with diabetic foot ulcer: A randomized, double-blind, placebo-controlled trial. Phytotherapy Research [Internet]. 2021 Apr [cited 2023 Dec 4]; 35(4): 2099–107. Available from:
Jayaprasad K, Ramu J, Iyer S, C R K, Pattatheyil A. Open Labelled Pilot Study of Topically Applied Curcumin Versus Standard Treatment on Chronic Wound Healing. IJCMR [Internet]. 2018 Oct [cited 2023 Dec 4]; 5(10). Available from:
Cao M, Duan Z, Wang X, Gong P, Zhang L, Ruan B. Curcumin Promotes Diabetic Foot Ulcer Wound Healing by Inhibiting miR-152-3p and Activating the FBN1/TGF-β Pathway. Mol Biotechnol [Internet]. 2024 Jan 11 [cited 2024 Jan 12]; Available from:
Hicks CW, Selvin E. Epidemiology of Peripheral Neuropathy and Lower Extremity Disease in Diabetes. Curr Diab Rep [Internet]. 2019 Aug 27 [cited 2024 Jan 18]; 19(10): 86. Available from:
Chatterjee N, Ekka NM, Mahajan M, Kumar B, Kumar N, Zia A, et al. Effectiveness of Topical Sucralfate in the Management of Diabetic Foot Ulcers: An Open-Labeled Randomized Study. Cureus [Internet]. 2023 Apr 14 [cited 2024 Jan 11]; 15(4). Available from:
Jiang P, Li Q, Luo Y, Luo F, Che Q, Lu Z, et al. Current status and progress in research on dressing management for diabetic foot ulcer. Front Endocrinol (Lausanne) [Internet]. 2023 Aug 17 [cited 2024 Jan 19]; 14: 1221705. Available from:
Agharazi M, Gazerani S, Huntington MK. Topical Turmeric Ointment in the Treatment of Diabetic Foot Ulcers: A Randomized, Placebo-Controlled Study. Int J Low Extrem Wounds. 2022 Dec 13; 15347346221143222.
[11]
Kumari A, Raina N, Wahi A, Goh KW, Sharma P, Nagpal R, et al. Wound-Healing Effects of Curcumin and Its Nanoformulations: A Comprehensive Review. Pharmaceutics [Internet]. 2022 Oct 25 [cited 2024 Jan 18]; 14(11): 2288. Available from:
Ruke, M., Iffat, Maurya, A., Bhise, A., Jose, J. A., et al. (2024). Effectiveness and Tolerability of Topical Curcumin for Management of Diabetic Foot Ulcer: A Pilot Clinical Study. International Journal of Diabetes and Endocrinology, 9(3), 56-60. https://doi.org/10.11648/j.ijde.20240903.11
Ruke, M.; Iffat; Maurya, A.; Bhise, A.; Jose, J. A., et al. Effectiveness and Tolerability of Topical Curcumin for Management of Diabetic Foot Ulcer: A Pilot Clinical Study. Int. J. Diabetes Endocrinol.2024, 9(3), 56-60. doi: 10.11648/j.ijde.20240903.11
Ruke M, Iffat, Maurya A, Bhise A, Jose JA, et al. Effectiveness and Tolerability of Topical Curcumin for Management of Diabetic Foot Ulcer: A Pilot Clinical Study. Int J Diabetes Endocrinol. 2024;9(3):56-60. doi: 10.11648/j.ijde.20240903.11
@article{10.11648/j.ijde.20240903.11,
author = {Milind Ruke and Iffat and Arun Maurya and Avinash Bhise and Jyolsna Agnes Jose and Kesavalu Purushothaman},
title = {Effectiveness and Tolerability of Topical Curcumin for Management of Diabetic Foot Ulcer: A Pilot Clinical Study
},
journal = {International Journal of Diabetes and Endocrinology},
volume = {9},
number = {3},
pages = {56-60},
doi = {10.11648/j.ijde.20240903.11},
url = {https://doi.org/10.11648/j.ijde.20240903.11},
eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijde.20240903.11},
abstract = {Background: Diabetic foot ulcers (DFUs) affect 9.1 to 26.1 million individuals globally each year, with 15-25% of those with diabetes mellitus (DM) experiencing them during their lives. DFUs are a major cause of amputations, accounting for 85% of such cases in diabetic patients. Curcumin, a compound from Curcuma longa, shows potential in wound healing through mechanisms such as inhibiting the NLRP3 inflammasome pathway, promoting autophagy, and regulating microRNA expression. This study evaluated the efficacy and safety of C3-DiagardTM Cream in treating DFUs. Methods: This open-label, prospective clinical study assessed the efficacy and safety of C3-DiagardTM cream, containing 0.05mg of Harida (Curcuma longa) extract, in treating and preventing DFUs. The cream was applied twice daily for 12 weeks. Key outcomes were assessed through wound size reduction, pain (VAS score), and any adverse reactions during the treatment. Results: Fifty DM patients (36 males, 14 females; mean age 57.58±12.67 years) were enrolled. Among the patients, 75% (38 individuals) showed a wound healing response between 70% and 99%. The average wound size decreased significantly from 6.63 cm2 at baseline to 1.83 cm2 after 12 weeks, with a mean reduction of 4.8 cm2 (p < 0.05). Pain levels, measured by VAS score, significantly dropped from an average of 8 to 3 (p < 0.05). No adverse reactions were reported, highlighting the cream’s safety. Conclusion: C3-DiagardTM cream is effective in reducing the size of diabetic foot ulcers and alleviating pain, with a favourable safety profile. This study supports the clinical use of C3-DiagardTM as a well-tolerated treatment option for patients with DFUs.
},
year = {2024}
}
TY - JOUR
T1 - Effectiveness and Tolerability of Topical Curcumin for Management of Diabetic Foot Ulcer: A Pilot Clinical Study
AU - Milind Ruke
AU - Iffat
AU - Arun Maurya
AU - Avinash Bhise
AU - Jyolsna Agnes Jose
AU - Kesavalu Purushothaman
Y1 - 2024/09/06
PY - 2024
N1 - https://doi.org/10.11648/j.ijde.20240903.11
DO - 10.11648/j.ijde.20240903.11
T2 - International Journal of Diabetes and Endocrinology
JF - International Journal of Diabetes and Endocrinology
JO - International Journal of Diabetes and Endocrinology
SP - 56
EP - 60
PB - Science Publishing Group
SN - 2640-1371
UR - https://doi.org/10.11648/j.ijde.20240903.11
AB - Background: Diabetic foot ulcers (DFUs) affect 9.1 to 26.1 million individuals globally each year, with 15-25% of those with diabetes mellitus (DM) experiencing them during their lives. DFUs are a major cause of amputations, accounting for 85% of such cases in diabetic patients. Curcumin, a compound from Curcuma longa, shows potential in wound healing through mechanisms such as inhibiting the NLRP3 inflammasome pathway, promoting autophagy, and regulating microRNA expression. This study evaluated the efficacy and safety of C3-DiagardTM Cream in treating DFUs. Methods: This open-label, prospective clinical study assessed the efficacy and safety of C3-DiagardTM cream, containing 0.05mg of Harida (Curcuma longa) extract, in treating and preventing DFUs. The cream was applied twice daily for 12 weeks. Key outcomes were assessed through wound size reduction, pain (VAS score), and any adverse reactions during the treatment. Results: Fifty DM patients (36 males, 14 females; mean age 57.58±12.67 years) were enrolled. Among the patients, 75% (38 individuals) showed a wound healing response between 70% and 99%. The average wound size decreased significantly from 6.63 cm2 at baseline to 1.83 cm2 after 12 weeks, with a mean reduction of 4.8 cm2 (p < 0.05). Pain levels, measured by VAS score, significantly dropped from an average of 8 to 3 (p < 0.05). No adverse reactions were reported, highlighting the cream’s safety. Conclusion: C3-DiagardTM cream is effective in reducing the size of diabetic foot ulcers and alleviating pain, with a favourable safety profile. This study supports the clinical use of C3-DiagardTM as a well-tolerated treatment option for patients with DFUs.
VL - 9
IS - 3
ER -
Ruke, M., Iffat, Maurya, A., Bhise, A., Jose, J. A., et al. (2024). Effectiveness and Tolerability of Topical Curcumin for Management of Diabetic Foot Ulcer: A Pilot Clinical Study. International Journal of Diabetes and Endocrinology, 9(3), 56-60. https://doi.org/10.11648/j.ijde.20240903.11
Ruke, M.; Iffat; Maurya, A.; Bhise, A.; Jose, J. A., et al. Effectiveness and Tolerability of Topical Curcumin for Management of Diabetic Foot Ulcer: A Pilot Clinical Study. Int. J. Diabetes Endocrinol.2024, 9(3), 56-60. doi: 10.11648/j.ijde.20240903.11
Ruke M, Iffat, Maurya A, Bhise A, Jose JA, et al. Effectiveness and Tolerability of Topical Curcumin for Management of Diabetic Foot Ulcer: A Pilot Clinical Study. Int J Diabetes Endocrinol. 2024;9(3):56-60. doi: 10.11648/j.ijde.20240903.11
@article{10.11648/j.ijde.20240903.11,
author = {Milind Ruke and Iffat and Arun Maurya and Avinash Bhise and Jyolsna Agnes Jose and Kesavalu Purushothaman},
title = {Effectiveness and Tolerability of Topical Curcumin for Management of Diabetic Foot Ulcer: A Pilot Clinical Study
},
journal = {International Journal of Diabetes and Endocrinology},
volume = {9},
number = {3},
pages = {56-60},
doi = {10.11648/j.ijde.20240903.11},
url = {https://doi.org/10.11648/j.ijde.20240903.11},
eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijde.20240903.11},
abstract = {Background: Diabetic foot ulcers (DFUs) affect 9.1 to 26.1 million individuals globally each year, with 15-25% of those with diabetes mellitus (DM) experiencing them during their lives. DFUs are a major cause of amputations, accounting for 85% of such cases in diabetic patients. Curcumin, a compound from Curcuma longa, shows potential in wound healing through mechanisms such as inhibiting the NLRP3 inflammasome pathway, promoting autophagy, and regulating microRNA expression. This study evaluated the efficacy and safety of C3-DiagardTM Cream in treating DFUs. Methods: This open-label, prospective clinical study assessed the efficacy and safety of C3-DiagardTM cream, containing 0.05mg of Harida (Curcuma longa) extract, in treating and preventing DFUs. The cream was applied twice daily for 12 weeks. Key outcomes were assessed through wound size reduction, pain (VAS score), and any adverse reactions during the treatment. Results: Fifty DM patients (36 males, 14 females; mean age 57.58±12.67 years) were enrolled. Among the patients, 75% (38 individuals) showed a wound healing response between 70% and 99%. The average wound size decreased significantly from 6.63 cm2 at baseline to 1.83 cm2 after 12 weeks, with a mean reduction of 4.8 cm2 (p < 0.05). Pain levels, measured by VAS score, significantly dropped from an average of 8 to 3 (p < 0.05). No adverse reactions were reported, highlighting the cream’s safety. Conclusion: C3-DiagardTM cream is effective in reducing the size of diabetic foot ulcers and alleviating pain, with a favourable safety profile. This study supports the clinical use of C3-DiagardTM as a well-tolerated treatment option for patients with DFUs.
},
year = {2024}
}
TY - JOUR
T1 - Effectiveness and Tolerability of Topical Curcumin for Management of Diabetic Foot Ulcer: A Pilot Clinical Study
AU - Milind Ruke
AU - Iffat
AU - Arun Maurya
AU - Avinash Bhise
AU - Jyolsna Agnes Jose
AU - Kesavalu Purushothaman
Y1 - 2024/09/06
PY - 2024
N1 - https://doi.org/10.11648/j.ijde.20240903.11
DO - 10.11648/j.ijde.20240903.11
T2 - International Journal of Diabetes and Endocrinology
JF - International Journal of Diabetes and Endocrinology
JO - International Journal of Diabetes and Endocrinology
SP - 56
EP - 60
PB - Science Publishing Group
SN - 2640-1371
UR - https://doi.org/10.11648/j.ijde.20240903.11
AB - Background: Diabetic foot ulcers (DFUs) affect 9.1 to 26.1 million individuals globally each year, with 15-25% of those with diabetes mellitus (DM) experiencing them during their lives. DFUs are a major cause of amputations, accounting for 85% of such cases in diabetic patients. Curcumin, a compound from Curcuma longa, shows potential in wound healing through mechanisms such as inhibiting the NLRP3 inflammasome pathway, promoting autophagy, and regulating microRNA expression. This study evaluated the efficacy and safety of C3-DiagardTM Cream in treating DFUs. Methods: This open-label, prospective clinical study assessed the efficacy and safety of C3-DiagardTM cream, containing 0.05mg of Harida (Curcuma longa) extract, in treating and preventing DFUs. The cream was applied twice daily for 12 weeks. Key outcomes were assessed through wound size reduction, pain (VAS score), and any adverse reactions during the treatment. Results: Fifty DM patients (36 males, 14 females; mean age 57.58±12.67 years) were enrolled. Among the patients, 75% (38 individuals) showed a wound healing response between 70% and 99%. The average wound size decreased significantly from 6.63 cm2 at baseline to 1.83 cm2 after 12 weeks, with a mean reduction of 4.8 cm2 (p < 0.05). Pain levels, measured by VAS score, significantly dropped from an average of 8 to 3 (p < 0.05). No adverse reactions were reported, highlighting the cream’s safety. Conclusion: C3-DiagardTM cream is effective in reducing the size of diabetic foot ulcers and alleviating pain, with a favourable safety profile. This study supports the clinical use of C3-DiagardTM as a well-tolerated treatment option for patients with DFUs.
VL - 9
IS - 3
ER -
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