RhizarthrosisNCT03020368
Effectiveness and Safety of Breeded Leech for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint
A study testing Leeches and Diclofenac in people with Rhizarthrosis, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Rhizarthrosis
- What is being tested?
- Leeches and Diclofenac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin am Immanuel-Krankenhaus
Berlin, 14109
About this study
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
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.
- Conditions
- Rhizarthrosis
- Being tested
- Leeches, Diclofenac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeechesBiological
Also called Hirudo verbana
DiclofenacDrug
| Study group | Role | What they receive |
|---|---|---|
| Leeches | Experimental | One-time topical application of 2-3 leeches ("medileech", Hirudo verbana) periarticularly on the painful thumb base Receives: Biological: Leeches |
| Diclofenac | Active comparator | 3 times daily topical application of Diclofenac gel (1 g with 10 mg diclofenac-Na) over 4 weeks Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder and Hand (DASH)
Measured: Change after 28 and 56 days
Secondary outcomes (2)
Visual analog scale (VAS)
Measured: Change after 7, 28 and 56 days
Medication on demand
Documentation in daily diary
Measured: Documentation between baseline and day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhizarthrosisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Prof. Dr., Principal investigator, Charite Centrum Epidemiologie und Gesundheitsökonomie, CC1: Gesundheitswissenschaften
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020368
- Sponsor's protocol ID
- Leeches for Rhizarthrosis
- Status last verified
- Feb 2019
- First submitted
- 11 Jan 2017
- Last updated
- 12 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03020368
- Acronym / sponsor ID
- Leeches for Rhizarthrosis
- Conditions
- Rhizarthrosis
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leeches | Experimental | Biological: LeechesOne-time topical application of 2-3 leeches ("medileech", Hirudo verbana) periarticularly on the painful thumb base |
| Diclofenac | Active comparator | Drug: Diclofenac3 times daily topical application of Diclofenac gel (1 g with 10 mg diclofenac-Na) over 4 weeks |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeechesAlso: Hirudo verbana | Biological | Leeches |
| Diclofenac | Drug | Diclofenac |
Primary outcome
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: Change after 28 and 56 days
2 secondary outcomes
Visual analog scale (VAS)
Time frame: Change after 7, 28 and 56 days
Medication on demand
Time frame: Documentation between baseline and day 56
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Michalsen, Prof. Dr. principal investigator
Charite Centrum Epidemiologie und Gesundheitsökonomie, CC1: Gesundheitswissenschaften
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leeches and Diclofenac in people with Rhizarthrosis, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder and Hand (DASH) (time frame: Change after 28 and 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.