Vol. 2, Issue 2, Part A (2025)

Background: Non-healing diabetic foot ulcers (DFU) remain a major cause of morbidity, recurrent hospitalisation and lower-limb amputation despite adherence to contemporary guideline-based management. In Ayurveda, such recalcitrant ulcers are correlated with Madhumehājanya Duṣṭa Vraṇa, in which vitiated Rakta and Tridoṣa at the distal extremities are addressed with Raktamokṣaṇa modalities, notably Sirāvedha.

Objectives: To assess the efficacy and safety of Raktamokṣaṇa by Sirāvedha as an adjuvant to standard care in the management of non-healing DFU.

Methods: In this prospective randomised controlled trial, 60 adults with type 2 diabetes and non-healing DFU (Wagner grade I-III, duration ≥6 weeks, adequate distal perfusion) were allocated to Group A (Sirāvedha + standard DFU care; n=30) or Group B (standard care alone; n=30). Sirāvedha was performed once weekly for four sittings at selected lower-limb venous sites under aseptic precautions, with blood volume tailored to patient status. Both groups received identical guideline-based DFU care including debridement, off-loading, infection control and metabolic optimisation. Primary outcome was percentage reduction in ulcer area at week 12; secondary outcomes included time to 50% area reduction, complete epithelialisation, granulation score, pain visual analogue scale (VAS), infection control and limb-salvage. Data were analysed on an intention-to-treat basis.

Results: Baseline characteristics were comparable between groups. At week 12, mean percentage reduction in ulcer area was significantly higher in Group A than Group B (78.4±16.2% vs 52.6±20.3%; p<0.001). Complete epithelialisation occurred in 60.0% versus 33.3% of patients (p=0.04), and a ≥50% area reduction was achieved in 80.0% versus 50.0% (p=0.02). Kaplan-Meier analysis showed earlier attainment of 50% area reduction in Group A (median 6 vs 9 weeks; log-rank p=0.003). Group a demonstrated greater improvement in granulation scores and larger reduction in pain VAS. Trends favoured Sirāvedha for reduced need for antibiotics and fewer minor/major amputations, though the latter did not reach statistical significance. Sirāvedha was well tolerated, with only mild, self-limiting adverse events.

Conclusion: Raktamokṣaṇa by Sirāvedha, used as an adjuvant to guideline-based DFU care, significantly enhances wound healing, granulation and pain relief in non-healing DFU, with an acceptable safety profile. These findings support the judicious, protocol-driven integration of Sirāvedha within multidisciplinary limb-salvage strategies and justify larger, multicentric trials with longer follow-up and mechanistic endpoints.