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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Efficacy of Platelets Rich Plasma Injection With PRGF Method in the Treatment for Osteoarthritis of the Subtalar Joint

NCT01422460

Osteoarthritis of Subtalar Joint

UNKNOWN NA

Platelet-rich Plasma for Thumb Carpometacarpal Joint Osteoarthritis

NCT04886349

Thumb Carpometacarpal Joint Osteoarthritis

COMPLETED

Assessment of Pain After Intra-articular Botulinum Toxin Injections in Carpometacarpal Osteoarthritis of the Thumb

NCT04829565

Rhizarthrosis

ACTIVE_NOT_RECRUITING PHASE4

A Study on the Effect of Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base

NCT04218591

Thumb Osteoarthritis

COMPLETED NA

Preparation Rich in Growth Factors (PRGF) Treatment for Osteoarthritis of the Knee

NCT00728611

Osteoarthritis of the Knee

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rhizarthrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Leeches

One-time topical application of 2-3 leeches ("medileech", Hirudo verbana) periarticularly on the painful thumb base

Group Type EXPERIMENTAL

Leeches

Intervention Type BIOLOGICAL

Diclofenac

3 times daily topical application of Diclofenac gel (1 g with 10 mg diclofenac-Na) over 4 weeks

Group Type ACTIVE_COMPARATOR

Diclofenac

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Leeches

Intervention Type BIOLOGICAL

Diclofenac

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Hirudo verbana

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No