Status:
COMPLETED
TRAUMED - a Clinical Trial in Acute Ankle Sprain
Lead Sponsor:
Biologische Heilmittel Heel GmbH
Conditions:
Ankle Sprain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
TRAUMED - a randomized clinical trial evaluating the efficacy and safety of Traumed® gel in patients with acute ankle sprain.
Detailed Description
Lateral ankle sprains are the most prevalent musculoskeletal injuries in physically active populations. They also have a high prevalence in the general population and pose a substantial healthcare bur...
Eligibility Criteria
Inclusion
- Acute unilateral Grade 1 or Grade 2 sprain of the lateral ankle.
- \>/=18 years of age.
- Legally competent male or female outpatient.
- Injury occurred within previous 24 hours before first treatment expected.
- Signed Informed Consent.
- After 5 minutes of rest, pain on passive movement by investigator measured by Visual Analog Scale (VAS) \>50 mm.
- Not pregnant or breast-feeding.
Exclusion
- Similar injury affecting the same joint within the past 6 months.
- Bilateral ankle injury.
- Grade 3 ankle sprain.
- Fracture of the ankle (It should be excluded by using e.g., the Ottawa Ankle Rules. In case of any doubt the exclusion of fracture by x-ray should be considered as per standard of care).
- Chronic joint disorders such as clinically relevant osteoarthritis or aseptic arthritis
- Disorders that may lead to joint oedema for other reasons than ankle sprain (such as heart failure, thrombosis, lymphedema and others).
- Diagnosis requiring bed rest, hospitalization, surgery, or use of any cast during the planned treatment period.
- Debilitating acute or chronic illness.
- Use of systemic and /or topical corticosteroids in the previous 8 weeks, any analgesics (e.g., paracetamol / acetaminophen) in the previous 24 hours before Screening Visit, or 48 hours in the case of long-acting NSAID, cyclooxygenase type 2 (COX-2) specific inhibitors, or tramadol and other opioids. Low dose acetylsalicylic acid (70 - 100 mg per day) for anti-thrombotic therapy is permitted if doses are stable for the month prior to Screening Visit and planned to be stable during the entire study.
- History of sensitivity to any component of the study drugs (including e.g. paracetamol / acetaminophen intolerance; patients in whom asthma attacks, skin rash or acute rhinitis are triggered by acetylsalicylic acid or non-steroidal anti-inflammatory drugs (NSAIDs).
- Unwilling or unable to comply with all the requirements of the study protocol.
- Concurrent injury to proximal structures in ipsilateral lower extremity (i.e., concurrent shin, knee, thigh, or hip injury).
- History of ligament avulsion, fracture or surgery to the affected lower extremity.
- Presence of infections and/or skin diseases in the area of the study treatment site (including psoriasis).
- Any previous treatments of the injured ankle, whether topical or systemic, are prohibited except RICE (simultaneous combination of all 4 elements; Rest, Ice, Compression and Elevation; which is restricted to be used until starting treatment with the investigational drug).
Key Trial Info
Start Date :
February 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2021
Estimated Enrollment :
809 Patients enrolled
Trial Details
Trial ID
NCT06192420
Start Date
February 26 2018
End Date
March 25 2021
Last Update
January 31 2024
Active Locations (1)
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1
UKSH Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105