American Society of Hirudotherapy

Investigating the therapeutic potential of medical leech and leech saliva extract in flap survival: an in vivo study using rats

Ünal K, Emre Erol M, Dayanır D, Deniz E, Ayhan H, Fındıkçıoğlu K (2025) · Journal of Complementary & Integrative Medicine · n=0

RCT evidence detailTrial reference
GRADE Very LowInsufficient evidence

Study Profile

Design
controlled animal experiment with three groups of female Wistar albino rats subjected to a dorsal random skin flap model (Gazi University Faculty of Medicine, Ankara, Turkey)
Sample size (n)
0
Intervention
Three groups: control (flap only), medicinal leech therapy (MLT) group, and leech saliva extract (LSE) injection group; histological, immunohistochemical (VEGF), and ELISA-based biochemical analyses performed at postoperative day 7
Comparator
Sham/control group (flap only without leech intervention)
Primary endpoint
Flap necrosis area, VEGF-positive cell percentage, neovascularization, epithelial regeneration, granulation tissue thickness, and inflammatory cell infiltration on postoperative day 7
Primary result
Flap necrosis area was significantly lower in both MLT and LSE groups versus control (p<0.05); VEGF-positive cells, neovascularization, epithelial regeneration, and granulation tissue thickness all significantly higher in MLT and LSE groups versus control (p<0.05); inflammatory cells substantially lower in LSE group versus control (p<0.05); first study to demonstrate the effect of medicinal leech extract injection in a flap model
Follow-up duration
7 postoperative days

Key Findings

  • First in vivo rat study to investigate medicinal leech saliva extract injection in a dorsal random flap model
  • Both medicinal leech therapy (MLT) and leech saliva extract (LSE) injection significantly reduced flap necrosis area
  • VEGF-positive cells, neovascularization, epithelial regeneration, and granulation tissue thickness were all enhanced in both leech groups
  • Leech saliva extract injection significantly reduced inflammatory cell infiltration
  • Provides molecular and histological mechanistic support for the clinical use of leech therapy in flap salvage

Limitations

  • Animal model (rat dorsal random flap) - direct human translation requires further study
  • Short follow-up (7 postoperative days) - long-term outcomes untested
  • Small sample size per arm (not specified per group in abstract)
  • Saliva extract concentration and standardization details unclear
  • Mechanism characterization limited to selected markers (VEGF, histology)

Clinical Implications

Ünal 2025 is a Turkish preclinical animal study that documents both whole-leech therapy and leech saliva extract injection produce significant histological and biochemical improvements in a dorsal random flap rat model. For ASH editorial purposes, the trial supports the mechanistic basis of leech therapy in flap salvage and adds preclinical support to the K040187-cleared indication. For US clinicians, the trial does not change practice but does provide modern animal-model evidence that the venous-decongestion mechanism is biologically operative. The saliva extract finding also supports future research on purified leech-derived biologics as alternatives to whole-leech device therapy.

Related Trials

This website provides educational information and does not constitute medical advice, diagnosis, or treatment recommendations. Medicinal leech therapy carries clinically meaningful risks and should be performed only by qualified clinicians under institutionally approved protocols. FDA 510(k) clearance for medicinal leeches is limited to specific indications; investigational and off-label discussions are labeled accordingly. For patient-specific guidance, consult a qualified healthcare provider.