Effectiveness and Safety of Breeded Leech for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint

Effectiveness and Safety of Breeded Leech Medileech by BioRepro GmbH for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint: a Randomized Controlled Clinical Trial

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03020368

Enrollment

Registered

2017-01-13

Start date

2017-01-31

Completion date

2018-12-31

Last updated

2019-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhizarthrosis

Brief summary

In this trial the investigators want to prove the efficacy and safety of a one-time topical leech application at patients with symptomatic primary arthrosis of the first carpometacarpal joint in comparison to the standard therapy with topical diclofenac.

Interventions

BIOLOGICALLeeches

DRUGDiclofenac

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Male and female patients aged 35 to 85 years * Pain intensity in the region of the thumb base in pain phases ≥ 40 mm on the VAS of 0 to 100 mm (relative to the last 24 hours) * Complaints for at least 3 months * X-ray Stadium Eaton I-IV at least once secured

Exclusion criteria

* Anticoagulation (Marcumar, Heparin) * Haemophilia, V. Willebrandt Jürgens syndrome, thrombocytopathy and other blood anomalies * Combination therapy of ASA and thienopyridines * Pain medication with opioid analgesics * Systemic medication with corticoids or immunosuppressants * Intraarterticular injections or RSO within the last 3 months * Past or planned surgery on the affected joint in the next 2 months * Pregnancy, lactation * Insulin-dependent type I diabetes mellitus * Acute psychotic disorders * Severe comorbidity

Design outcomes

Primary

Measure	Time frame
Disabilities of the Arm, Shoulder and Hand (DASH)	Change after 28 and 56 days

Secondary

Measure	Time frame	Description
Visual analog scale (VAS)	Change after 7, 28 and 56 days	—
Medication on demand	Documentation between baseline and day 56	Documentation in daily diary

Other

Measure	Time frame	Description
Expectation	Baseline	5-stage Likert scale for the expectation of symptomatic efficacy after group assignment
Overall assessment of efficacy and tolerability	Day 56	5-stage Likert scale documented by the patient as well as by the doctor at the end of the study

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026