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

February 11, 2019 updated by: Andreas Michalsen, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14109
        • Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin am Immanuel-Krankenhaus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Leeches
One-time topical application of 2-3 leeches ("medileech", Hirudo verbana) periarticularly on the painful thumb base
Biological: Leeches
Other Names:
  • Hirudo verbana
ACTIVE_COMPARATOR: Diclofenac
3 times daily topical application of Diclofenac gel (1 g with 10 mg diclofenac-Na) over 4 weeks
Drug: Diclofenac

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (ESTIMATE)

January 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Leeches for Rhizarthrosis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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