TRAUMED - a Clinical Trial in Acute Ankle Sprain

• Status: Completed
• Trial end date: 2021-03-25
• Target enrollment: 0
• Participant gender: All

Summary

TRAUMED - a randomized clinical trial evaluating the efficacy and safety of Traumed® gel in patients with acute ankle sprain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biologische Heilmittel Heel GmbH
• Treatments: Diclofenac

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).