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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03020368
• Date of registration: 11/01/2017
• Prospective Registration: No
• Primary sponsor: Charite University, Berlin, Germany
• Public title: Effectiveness and Safety of Breeded Leech for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint
• Scientific title: Effectiveness and Safety of Breeded Leech "Medileech" by BioRepro GmbH for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint: a Randomized Controlled Clinical Trial
• Date of first enrolment: January 2017
• Target sample size: 52
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03020368
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Andreas Michalsen, Prof. Dr.
• Affiliation: Charite Centrum Epidemiologie und Gesundheitsökonomie, CC1: Gesundheitswissenschaften

Key inclusion & exclusion criteria

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



Age minimum: 35 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rhizarthrosis

Intervention(s)

Drug: Diclofenac

Biological: Leeches

Primary Outcome(s)

Disabilities of the Arm, Shoulder and Hand (DASH) [Time Frame: Change after 28 and 56 days]

Secondary Outcome(s)

Medication on demand [Time Frame: Documentation between baseline and day 56]

Visual analog scale (VAS) [Time Frame: Change after 7, 28 and 56 days]

Secondary ID(s)

Leeches for Rhizarthrosis

Source(s) of Monetary Support

Please refer to primary and secondary sponsors