TRAUMED - a Clinical Trial in Acute Ankle Sprain

NCT06192420 | Completed Phase 3

• 2 other identifiers: C15022016-004792-50
• Study Type: interventional
• Target: 809
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ankle Sprain

Keywords

Double blind clinical trial; Active and placebo controlled clinical trial; Leg injury

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve (AUC)* for pain on passive movement in Visual Analog Scale (VAS) from Baseline to Day 4.

  Ankle pain is assessed via a 100 mm VAS, where zero mm indicates 'no pain' and 100 mm indicates the 'most severe imaginable pain' in relation to the participant's ankle sprain. After 5 minutes rest, participants first assess their ankle sprain pain on a 100 mm VAS for a secondary efficacy assessment. With the participant still at rest, the investigator performs 10° dorsal-flexion and 30° plantar-flexion of the sprained ankle, before participants re-assess their pain on a 100 mm VAS.

  Baseline and Day 4

• Area Under the Curve (AUC) for pain on passive movement in Visual Analog Scale (VAS) from Baseline to Day 7 as per SAP version 1.0.

  Ankle pain is assessed via a 100 mm VAS, where zero mm indicates 'no pain' and 100 mm indicates the 'most severe imaginable pain' in relation to the participant's ankle sprain. After 5 minutes rest, participants first assess their ankle sprain pain on a 100 mm VAS for a secondary efficacy assessment. With the participant still at rest, the investigator performs 10° dorsal-flexion and 30° plantar-flexion of the sprained ankle, before participants re-assess their pain on a 100 mm VAS.

  Baseline and Day 7

Secondary Outcomes (9)

• AUC for pain at rest in VAS from Baseline to Day 4.

  Baseline and Day 4

• AUC for pain on passive movement in VAS from Baseline to Day 2, 7 and Final Visit.

  Baseline, Day 2, Day 7 and Day 14

• AUC for pain at rest in VAS from Baseline to Day 2, 7 and Final Visit.

  Baseline, Day 2, Day 7 and Day 14

• Change from Baseline of pain on passive movement in VAS to Day 4, 7 and Final Visit.

  Baseline, Day 4, Day 7 and Day 14

• Change from Baseline of pain at rest in VAS to Day 4, 7 and Final Visit.

  Baseline, Day 4, Day 7 and Day 14

Study Arms (3)

Test product

EXPERIMENTAL

Traumed® gel (human gel galenic form of Traumeel®)

Drug: Traumeel®

Reference product

ACTIVE COMPARATOR

Diclofenac sodium gel 1%

Drug: Diclofenac sodium gel 1%

Placebo therapy

PLACEBO COMPARATOR

Corresponding placebo gel

Drug: Placebo

Interventions

Traumeel® DRUG

3g of gel three times daily for 7days (+1 day visit window)

Also known as: Traumed® gel

Test product

Diclofenac sodium gel 1% DRUG

3g of gel three times daily for 7days (+1 day visit window)

Also known as: Diclofenac Heumann gel

Reference product

Placebo DRUG

3g of gel three times daily for 7days (+1 day visit window)

Also known as: Placebo gel

Placebo therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Similar injury affecting the same joint within the past 6 months.
• Bilateral ankle injury.
• Grade 3 ankle sprain.
• 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).

Sponsors & Collaborators

• Biologische Heilmittel Heel GmbH: lead

Study Sites (1)

UKSH Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

Location

Related Publications (1)

• Gerdesmeyer L, Pabst H, Cesnulevicius K, Schultz M, Smit A, Kerkhoffs G. Tr14 gel for the treatment of acute ankle sprains: a plain language summary of the TRAUMED trial. J Comp Eff Res. 2025 Jul;14(7):e250018. doi: 10.57264/cer-2025-0018. Epub 2025 Jun 5.

  PMID: 40468690 DERIVED

MeSH Terms

Conditions

Ankle Injuries; Motor Activity; Leg Injuries

Interventions

Traumeel S

Condition Hierarchy (Ancestors)

Wounds and Injuries; Behavior

Study Officials

• Thomas Becker, Prof,PhD,MD

  UKSH Universitätsklinikum Schleswig-Holstein, Campus Kiel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: CRO (including CRAs)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, active- and placebo-controlled confirmatory clinical trial

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: January 5, 2024
• Study Start: February 26, 2018
• Primary Completion: November 18, 2020
• Study Completion: March 25, 2021
• Last Updated: January 31, 2024

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)