Sociedad Americana de Hirudoterapia

Plantar Fibromatosis (Ledderhose Disease)

Investigational use for plantar fascia nodules in early Ledderhose disease; case-series evidence for symptomatic improvement.

Tier C — InvestigationalInvestigacionalLast updated: 2026-05-26 · Reviewed by ASH Editorial Board

Resumen para el Paciente

¿Está esto autorizado por FDA para este uso?
Not FDA-cleared for plantar fibromatosis. FDA cleared medicinal leeches only for venous congestion in microsurgical reconstruction (K040187, June 2004). Use for Ledderhose disease is investigational.
¿Qué evidencia existe?
Tier C (investigational). One small case series (n=10) reports symptomatic pain reduction and nodule softening at 16 weeks; there are no randomized controlled trials. Established options for symptomatic plantar fibromatosis include custom orthotic accommodation (first-line), low-dose radiotherapy for early disease, and surgical excision for advanced disease (with high recurrence rates and risk of plantar nerve injury). Most asymptomatic nodules require only observation.
Riesgos principales
  • Bleeding from bite sites for 6 to 24 hours after detachment
  • Bruising and tenderness on the plantar surface
  • Local skin infection or, rarely, Aeromonas infection
  • Allergic reaction to leech saliva (uncommon)
  • Worsening pain after the procedure (transient)
  • Risk if a leech is placed too close to a plantar nerve or rupture site
  • Difficulty bearing weight for several days after treatment
  • Delay of orthotic accommodation, radiotherapy, or surgical evaluation
Quién no debería considerar esto
  • Patients with active plantar fascial rupture or ulceration
  • Patients with diabetic peripheral neuropathy (reduced protective sensation at bite site)
  • Patients with peripheral arterial disease severe stenosis (ABI <0.6)
  • Patients on anticoagulants, with hemophilia, or with severe anemia
  • Pregnant patients
  • Patients who have not tried custom orthotic accommodation
Qué preguntar a su clínico
  • Have I tried custom orthotic accommodation and activity modification?
  • Have I been evaluated for low-dose radiotherapy in early-stage disease?
  • Is my diabetic foot exam normal (sensation, pulses, ABI)?
  • What evidence specifically supports leech therapy for plantar fibromatosis?
  • Are leeches from an FDA-registered supplier and used only once?
  • What is the practitioner's Aeromonas-prevention plan?
  • What is the cost and is it covered by insurance? (typically not covered)
Cuándo buscar atención urgente
  • Inability to bear weight or new severe foot pain after treatment
  • Numbness or tingling in the foot (possible nerve injury)
  • Spreading redness, warmth, pus, or red streaks (cellulitis)
  • Fever above 38.0 C / 100.4 F or chills
  • Bleeding from a bite site lasting more than 24 hours
  • Hives, facial or tongue swelling, throat tightness, or breathing difficulty

Qué NO significa esto

  • This is NOT FDA-cleared for plantar fibromatosis.
  • A single n=10 case series does NOT establish efficacy versus orthotic accommodation, low-dose radiotherapy, or surgical excision.
  • It does NOT cure Ledderhose disease — recurrence is common.
  • It does NOT replace a thorough diabetic foot exam before any lower-extremity procedure.
  • It does NOT substitute for orthopedic or podiatric evaluation in symptomatic disease.

Clinical Profile

Category
musculoskeletal
ICD-10
M72.2
Safety tier
low

Evidence Summary

Plantar fibromatosis (Ledderhose disease), the plantar analogue of Dupuytren's disease, has limited conservative options. No controlled clinical trial or credible case series of leech therapy for this condition has been published; there is no reliable evidence of pain reduction or nodule softening. Any proposed antifibrotic mechanism is speculative and unproven. Established large or symptomatic nodules may require radiotherapy or surgical excision (which carries a high recurrence rate), and custom orthotic accommodation can help with footwear tolerance. ASH position: any use of leech therapy for plantar fibromatosis is investigational and mechanistic only.

Treatment specifics

How many leeches, where they are placed, how long a session lasts, and whether to repeat are clinical decisions made by a qualified provider under institutional protocol — not something to self-administer. Discuss the specifics with a clinician experienced in medicinal leech therapy. (Clinicians: switch the audience selector in the top bar to “Clinician” to view protocol detail.)

Key Trials

  1. Singh A et al. (2021), n=10

Contraindications

  • Active anticoagulant therapy (warfarin INR >2.0, DOACs, heparin)
  • Hemophilia or other bleeding disorder
  • Severe anemia (Hb <10 g/dL)
  • Active bacteremia or sepsis
  • Known hypersensitivity to leech salivary proteins
  • Pregnancy (relative — first/third trimester)
  • Immunocompromised state with severe neutropenia
  • Active plantar fascial rupture or ulceration
  • Diabetic peripheral neuropathy

Related Conditions

Este sitio web proporciona información educativa y no constituye consejo médico, diagnóstico ni recomendaciones de tratamiento. La terapia con sanguijuelas medicinales conlleva riesgos clínicamente significativos y debe ser realizada únicamente por profesionales calificados bajo protocolos aprobados institucionalmente. La autorización 510(k) de la FDA para sanguijuelas medicinales se limita a indicaciones específicas; las discusiones sobre uso investigativo y fuera de indicación se señalan correspondientemente. Para orientación médica específica, consulte a un profesional de salud calificado.

Plantar Fibromatosis (Ledderhose Disease) — Hirudotherapy Evidence | ASH