Effectiveness and Safety of Breeded Leech for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 11, 2017
CompletedFirst Posted
Study publicly available on registry
January 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 12, 2019
February 1, 2019
1.9 years
January 11, 2017
February 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Disabilities of the Arm, Shoulder and Hand (DASH)
Change after 28 and 56 days
Secondary Outcomes (2)
Visual analog scale (VAS)
Change after 7, 28 and 56 days
Medication on demand
Documentation between baseline and day 56
Other Outcomes (2)
Expectation
Baseline
Overall assessment of efficacy and tolerability
Day 56
Study Arms (2)
Leeches
EXPERIMENTALOne-time topical application of 2-3 leeches ("medileech", Hirudo verbana) periarticularly on the painful thumb base
Diclofenac
ACTIVE COMPARATOR3 times daily topical application of Diclofenac gel (1 g with 10 mg diclofenac-Na) over 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin am Immanuel-Krankenhaus
Berlin, 14109, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Michalsen, Prof. Dr.
Charite Centrum Epidemiologie und Gesundheitsökonomie, CC1: Gesundheitswissenschaften
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 11, 2017
First Posted
January 13, 2017
Study Start
January 1, 2017
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
February 12, 2019
Record last verified: 2019-02