American Society of Hirudotherapy

Tarsal Tunnel Syndrome

Investigational use for posterior tibial nerve entrapment at the medial ankle; very limited case-report evidence.

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

Patient Summary

Is this FDA-cleared for this use?
Not FDA-cleared for tarsal tunnel syndrome. FDA cleared medicinal leeches only for venous congestion in microsurgical reconstruction (K040187, 2004). Use here is investigational.
What evidence exists?
Tier C (investigational). There are no published controlled trials. Evidence-based care: orthotics and supportive footwear, activity modification, NSAIDs, physical therapy with intrinsic foot strengthening and Achilles stretching, electrodiagnostic testing to stage severity, ultrasound or MRI to identify space-occupying lesions (ganglion, varicose veins, accessory muscles), local corticosteroid injection, and (refractory) tarsal tunnel release surgery. Diabetic peripheral neuropathy mimics tarsal tunnel and must be distinguished.
Main risks
  • Bleeding from each bite site for 6 to 24 hours after detachment
  • Bruising over the medial ankle for 5 to 10 days
  • Local skin or, rarely, Aeromonas hydrophila infection
  • Allergic reaction to leech saliva (uncommon)
  • RISK if leech is placed directly over the tarsal tunnel or posterior tibial nerve
  • Worsening paresthesia from local tissue swelling near the nerve
  • Delay of imaging if a space-occupying lesion is responsible
  • Delay of surgical release in patients with motor weakness who need it
  • RISK in diabetic patients with reduced sensation and impaired healing
Who should not consider this
  • Patients with diabetes, peripheral arterial disease, or impaired protective sensation on monofilament testing
  • Patients with intrinsic foot muscle wasting or motor weakness (this needs surgical release)
  • Patients without electrodiagnostic confirmation
  • Patients without imaging to exclude space-occupying lesions (ganglion, varicose veins, accessory muscles, tenosynovitis)
  • Patients who have not tried orthotics, supportive footwear, and physical therapy
  • Patients on anticoagulants, with hemophilia, or with severe anemia
  • Patients with active dermatitis or broken skin over the medial ankle
What to ask your clinician
  • Have I had electrodiagnostic testing (nerve conduction studies)?
  • Have I had ultrasound or MRI to look for space-occupying lesions (ganglion, varicose veins, accessory muscles)?
  • Have we ruled out diabetic peripheral neuropathy or lumbar radiculopathy as alternatives?
  • Have I tried orthotics, supportive footwear, NSAIDs, and physical therapy?
  • Am I a candidate for local corticosteroid injection or surgical tarsal tunnel release?
  • Where exactly will the leech be placed - confirm it is NOT directly over the tarsal tunnel or posterior tibial nerve?
  • What is the Aeromonas-prevention protocol given the foot is a higher-risk area?
When to seek urgent care
  • Sudden severe foot weakness, foot drop, or inability to push off
  • Sudden numbness in the entire sole of the foot
  • Acute swelling, severe pain, or cold pallor of the foot
  • Non-healing wound or ulcer at the bite site
  • Bleeding from a bite site lasting more than 24 hours
  • Fever, chills, or spreading redness at the bite site
  • Hives, facial or throat swelling, or breathing difficulty

What this does NOT mean

  • This is not FDA-cleared for tarsal tunnel syndrome.
  • No controlled trials support efficacy.
  • It does not address space-occupying lesions (ganglion, varicose veins, accessory muscles), which need imaging and possibly surgery.
  • It does not replace orthotics, supportive footwear, and physical therapy - which have stronger evidence.
  • Foot procedures in diabetic patients carry uniquely high infection and non-healing risk.

Clinical Profile

Category
neurological
ICD-10
G57.50, G57.51, G57.52
Safety tier
low

Evidence Summary

Tarsal tunnel syndrome is an uncommon and frequently underdiagnosed entrapment of the posterior tibial nerve behind the medial malleolus. Conventional management includes orthotics, neuropathic pain agents, and surgical release. No controlled clinical trial or case report of leech therapy for tarsal tunnel syndrome has been published; use is investigational and mechanistic only. Diagnostic overlap with plantar fasciitis and S1 radiculopathy means MRI, ultrasound, and electrodiagnostics should confirm the diagnosis before any complementary therapy is considered.

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. Sharma D et al. (2022)0

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
  • Space-occupying lesion in tarsal tunnel (ganglion, lipoma) — surgical
  • Active medial ankle infection
  • Diabetic peripheral neuropathy with ulceration

Related Conditions

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.

Tarsal Tunnel Syndrome — Hirudotherapy Evidence | ASH