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Soft Tissue Injury clinical trials

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NCT ID: NCT05026320 Completed - Soft Tissue Injury Clinical Trials

A Clinical Trial to Compare Safety and Effectiveness for Relieving Tenderness of 10% Naproxen Gel vs. a 2.32% Diclofenac Diethylamine Gel in the Treatment of Strains and Bruises of the Legs.

Start date: August 8, 2021
Phase: Phase 2
Study type: Interventional

Researchers are looking for a different way to treat people who have an injury to their muscles, ligaments, or tendons in their legs or feet. This is known as a "soft tissue" injury. Before a treatment is available to all patients, researchers study it in trials to better understand its safety and how well it works. People with soft tissue injuries can have pain, swelling, and bruising. In this trial, the researchers want to learn more about the trial treatment, BAYH006689, in participants with a soft tissue injury to their legs or feet. BAYH006689 is a naproxen gel that is used for the temporary relief of minor aches and pains of muscles and joints. The researchers will learn more about how BAYH006689 works and how safe it is in these participants. The trial will include about 100 male and female participants between the ages of 18 and 60. All the participants will have a soft tissue injury to their legs or feet that was caused by playing sports. The injury will have happened within 3 hours of joining the trial. The researchers will use a computer program to randomly choose what treatment each participant will receive. This will help make sure the treatments are chosen fairly and that comparing the results of the treatments is as accurate as possible. The participants will be randomly chosen to be in 1 of 3 groups: - Group 1: 4 grams (g) of BAYH006689 - Group 2: 4 g of a diclofenac diethylamine gel - Group 3: 4 g of a placebo A placebo looks like a treatment but does not have any medicine in it. Diclofenac diethylamine gel is a treatment already available for doctors to be recommended to people with soft tissue injuries. The participants will receive their treatment once in the evening on Day 1 and then 2 times a day for 4 days. The participants will receive their final dose in the morning of Day 6. The doctors will apply the treatment to the participants' skin where the injury is. The participants must be present at the clinic site 11 times over six days: once on Day 1 and twice daily on Days 2-6. During the trial, the doctors will: - check the participants' overall health and ask if they have any medical problems - do physical examinations to check the participants' injuries - use a device to see how tender and sore the participants' injuries are In this trial, the researchers will study how tender the participants' injuries are after 3 days and at other time points over the 6 day follow-up period. They will also study how many participants have medical problems during the trial.

NCT ID: NCT02145130 Completed - Scars Clinical Trials

Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects

Start date: May 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is the evaluation of the safety of autologous tissue-engineered dermal substitutes "denovoDerm" (first arm) and dermo-epidermal skin substitutes "denovoSkin" (second arm) transplanted onto the wound bed in children and adults.

NCT ID: NCT01292876 Completed - Muscle Injury Clinical Trials

Musculotendinous Tissue Repair Unit and Reinforcement (MTURR)

MTURR
Start date: December 2010
Phase: N/A
Study type: Interventional

The objective of the study is to assess mechanical strength and function in subjects undergoing Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) with the use of biologic scaffolds for the restoration of both mechanical strength and function in these subjects. This study formally evaluated healing and return of function after an extracellular matrix device implantation in 17 male and female subjects participating at the University of Pittsburgh under the Department of Plastic and Reconstructive Surgery who suffer from injury with loss of skeletal muscle tissue.

NCT ID: NCT00931866 Completed - Acute Pain Clinical Trials

Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED)

Start date: April 2009
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing mild to moderate soft tissue injuries when applied to the painful area.

NCT ID: NCT00796094 Completed - Soft Tissue Injury Clinical Trials

Imaging of Soft Tissues

Start date: December 2008
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the potential importance of tissue elasticity in the assessment of soft tissues including muscles, tendons and ligaments and other soft tissue structures. The evaluation of tissue elasticity (easily stretched or moveable) may assist in assessment of various soft tissue structures, such as fatty atrophy of muscles, tendon/ligamentous injury and healing and other soft tissue structures.

NCT ID: NCT00537784 Completed - Clinical trials for Achilles Tendon Rupture

Platelet Concentrate in Achilles Tendon Repair

Start date: September 2007
Phase: N/A
Study type: Interventional

People operated for a rupture of the Achilles tendon receive a concentrate of their own platelets injected into the operated area. The study is randomized and single-blinded, with 20 treated patients and 20 controls, who get no injection. The primary endpoint is a mechanical property of the tendon after 12 weeks (modulus of elasticity), as measured by a special type of radiography. This radiography uses 0.8 mm metal markers, which are injected into the tendon. The tendon is mechanically loaded during radiography and its strain can be measured as increased distance between the markers. Other mechanical variables at 6, 12 and 52 weeks are secondary variables, as well as a validated patient-administrated questionaire at 1 year.

NCT ID: NCT00264511 Completed - Tibial Fracture Clinical Trials

Hyperbaric Oxygen in Lower Leg Trauma

Start date: February 13, 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Study hypothesis :Hyperbaric Oxygen may prevent complications and improve outcomes in severe lower limb trauma. We propose to investigate this hypothesis by conducting an International multi centre randomised control trial of standard trauma/orthopaedic care with or without a concurrent course of hyperbaric oxygen treatments.