Individualized Homoeopathic Intervention (IHI) in Diabetic Foot Ulcer (DFU): A Randomized Controlled Pilot Study (RCPS) using Calendula Q vs. Normal Saline (NS) for Ulcer Dressing

Background and Objectives: Despite standard management strategies, healing rates of diabetic foot ulcers (DFUs) remain low and complete healing remains a challenge posing risk of lower extremity amputation (LEA). Meta-analysis of 10 control groups of clinical trials, using good standard wound care, demonstrated the weighted mean rates of healing of 24.2% over 12 weeks and 30.9% over 20 weeks. A study with individualized homoeopathic intervention (IHI) + Calendula dressings showed mean rates of healing of 90.5% over 12 weeks, significant when compared with accepted duration for healing studies. The present study was undertaken to evaluate if Calendula Q has added benefit over IHI. The primary objective is to achieve complete epithelialisation within 20 weeks and secondarily to assess the changes in QOL using DFU Scale—Short Form (DFU-SF) questionnaire.

Methods/Design: Unicentric, randomized controlled pilot study (RCPS) with a 20-week intervention is being conducted since May 2014. Two hundred and sixteen cases screened and cases fulfilling eligibility criteria are enrolled (n = 34), randomized into IHI with Calendula Q dressing, Group I (n = 23) or IHI with normal saline (NS) dressing, Group II (n = 11) to maintain wound hygiene along with routine diabetic conventional medication for sugar control.

Result: Interim analysis is done for the 30 completed cases (Group I, n = 19, 63.3% and Group II, n = 11, 36.7%). There is statistically no significant difference (p = 0.671) found in mean time of ulcer healing in both groups affirming the efficacy of IHI irrespective of the medication used in dressing. The mean healing time found to be much less when compared with previous studies (Group I = 11 weeks, Group II = 10 weeks). Arsenic album (n = 11, 36.7%) and Silicea (n = 12, 40%) were the most frequently indicated medicines.

Conclusion: Add-on IHI with standard conventional diabetic management and wound hygiene can effectively lead to early, complete epithelialisation of Wagner's first, secondstage of DFUs, reduction in the incidence of LEA, and usage of antibiotics and financial burden. Further RCTs are to be undertaken with standard treatment strategy to establish IHI for early wound healing to prevent LEA.

Keywords: Homoeopath, DFU, DFU-SF, Calendula, wound hygiene

No conflict of interest has been declared by the author(s).