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

Rhizarthrosis Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03020368
• Other study ID #: Leeches for Rhizarthrosis
• Status: Terminated
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Rhizarthrosis

Intervention

Biological:
• Leeches

Drug:
• Diclofenac

Locations

Country	Name	City	State
Germany	Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin am Immanuel-Krankenhaus	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Expectation	5-stage Likert scale for the expectation of symptomatic efficacy after group assignment	Baseline
Other	Overall assessment of efficacy and tolerability	5-stage Likert scale documented by the patient as well as by the doctor at the end of the study	Day 56
Primary	Disabilities of the Arm, Shoulder and Hand (DASH)		Change after 28 and 56 days
Secondary	Visual analog scale (VAS)		Change after 7, 28 and 56 days
Secondary	Medication on demand	Documentation in daily diary	Documentation between baseline and day 56