Use of leech therapy in management of diabetic foot ulcer: a randomized controlled pilot trial
Nayak S, Mishra T, Pradhan SC, Sahoo S, Sharma A, Choudhury S (2008) · Indian Journal of Surgery · n=42
RCT evidence detailTrial reference
GRADE Very LowInsufficient evidence
Study Profile
- Design
- single-center, open-label, randomized controlled trial (Bhubaneswar, India)
- Sample size (n)
- 42
- Intervention
- Daily leech application (Hirudinaria granulosa, 1-2 leeches) to ulcer margins for up to 14 days, plus standard wound care
- Comparator
- Standard wound care only (debridement, saline dressing, glucose control)
- Primary endpoint
- Percent reduction in ulcer area at day 28
- Primary result
- Ulcer area reduction 73% in leech vs 41% in standard care at day 28 (p=0.02); time to complete granulation 18.4 days vs 26.8 days
- Effect size (Cohen's d)
- 0.74
- Follow-up duration
- 12 weeks
Key Findings
- First RCT for hirudotherapy in diabetic foot ulcer
- Granulation tissue formation accelerated in leech arm
- No infections despite open wound — leech-borne Aeromonas concern not realized in this small series
- All patients received ciprofloxacin prophylaxis
- Used H. granulosa (Indian species)
Limitations
- Small sample (n=42)
- Open-label
- No standardized ulcer staging at baseline (Wagner grade reported but not stratified)
- Short follow-up — recurrence and major amputation not assessed
- Antibiotic prophylaxis may obscure leech-specific anti-infection effects
Clinical Implications
Nayak 2008 is the only RCT-level evidence for leech therapy in diabetic foot ulcer. The result is encouraging but exploratory. For US clinicians, this indication is not FDA-cleared and the trial uses a non-US leech species. The mechanism (improved microcirculation via salivary vasodilators + anti-platelet effects) is biologically plausible but requires larger confirmatory trials before clinical adoption can be recommended.