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Soft Tissue Injuries clinical trials

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NCT ID: NCT05171673 Recruiting - Clinical trials for Soft Tissue Injuries

Study of PK and Safety of the LicartTM Topical System in Pediatric and Adult Participants With Minor Soft Tissue Injury

Start date: October 31, 2021
Phase: Phase 3
Study type: Interventional

A multi-center, prospective, open-label, controlled study of the pharmacokinetics and safety of the LicartTM topical system in pediatric and adult participants with minor soft tissue injuries. 150 male and female participants aged 6-16 and 18-45 with soft tissue injuries meeting the following criteria will be enrolled to evaluate the pharmacokinetics and safety of the Licart topical system in pediatric and adult participants with minor soft tissue injuries over a 14-day treatment course. The analgesic effects will also be evaluated of the topical system in pediatric and adult participants with minor soft tissue injuries over a 14-day treatment course. To collect principal investigator-reported global response to therapy.

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: NCT04908748 Completed - Clinical trials for Soft Tissue Injuries

Efficacy and Safety of Esflurbiprofen Hydrogel Patch in the Treatment of Local Acute Pain

Start date: May 20, 2021
Phase: Phase 2
Study type: Interventional

Objective of this study is: to determine efficacy and safety of a Esflurbiprofen Hydrogel Patch compared to placebo in patients with acute strains, sprains or bruises of the extremities following blunt trauma, e.g. sports injuries. to demonstrate that the Esflurbiprofen Hydrogel Patch is superior to placebo, and that the patch has acceptable local tolerability.

NCT ID: NCT04802473 Completed - Clinical trials for Periodontal Diseases

Flap Thickness Upon Root Coverage With the Use of Acellular Dermal Matrix

Start date: July 9, 2020
Phase: N/A
Study type: Interventional

OrACell has been tested as a barrier in bone regenerative procedures showing promising results in new bone formation after socket preservation, but no data is available on root coverage procedures. Moreover, it has been suggested that keratinized tissue width (KTW) ≥2mm and gingival thickness (GT) ≥1.2 mm at 6 months of the surgical procedures are two important predictors for long term stability of gingival margin Therefore, it was hypothesized that soft tissue thickness and keratinized tissue width may influence the percentage of root coverage. By means of a prospective case series (12 patients in total), the aim is to study the performance of the OrACell dermal matrix in the treatment of multiple and adjacent gingival recessions, determining the amount of complete root coverage obtained at 6 months of follow-up. At the same time, it is intended to evaluate the effect of initial gingival thickness, by means of digital scanning, upon the success of root coverage procedure with OrACell.

NCT ID: NCT04669704 Completed - Clinical trials for Carpal Tunnel Syndrome

Effectiveness of a Tele-Rehabilitation Evidence-based Tablet App for Rehabilitation in Traumatic Bone and Soft Injuries of the Hand, Wrist and Fingers.

Start date: January 20, 2021
Phase: N/A
Study type: Interventional

Trauma and soft injuries of the wrist, hand and fingers have a high incidence, and large social and healthcare costs are generated, mainly due to productivity loss. Therapeutic exercises must be part of the treatment and in the last 10 years the scientific literature highlights the need for the inclusion of the sensorimotor system in both surgical and rehabilitative approaches. Current methods as leaflets or videos lacks of adherence control, evolution control and knowledge of how the patient do the exercises which compromise the expected results. Touch-screens of Tablet devices have showed a large potential to cover these needs and for the retraining of sensorimotor system. ReHand is a Tablet digital tool (Android and iOS) to prescribe and monitor exercise programs based on sensorimotor approach and developed under the guidelines of various healthcare professionals (hand surgeons, physiotherapists, rehabilitators and occupational therapists) to implement home exercise programs and monitor patients. Subjects are selected by emergency, hand surgery, rehabilitation and physiotherapy services of six hospitals from Andalusian Public Health Service through consecutive sampling. Concretely, patients over 18 years of age with trauma and soft injuries of the wrist, hand and fingers, no more than 10 days after surgery or removal of immobilization. Experimental group will receive access to ReHand app to perform a monitored home exercises program. Control group will receive the conventional method employed: a home exercise program in paper with recommendations. Clinical variables will be assessed at baseline before group allocation, 4 weeks, 3 months and 6 months. At the end of the study, cost-utility variables will be analyzed.

NCT ID: NCT04569305 Completed - Clinical trials for Soft Tissue Injuries

Effect of Negative Pressure Wound Therapy for Soft Tissue Injuries of Foot and Ankle in Patients at a Tertiary Care Hospital

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Effect of Negative Pressure Wound Therapy for Soft Tissue Iinjuries of Foot and Ankle in Patients at a Tertiary care Hospital. To evaluate the effect of negative pressure wound therapy for soft tissue injuries of foot and ankle.This will be assessed through measuring the wound surface area covered with healthy granulation tissue measured in centimetre square on follow-up.

NCT ID: NCT04361773 Not yet recruiting - Clinical trials for Soft Tissue Injuries

Effect of Photobiomodulation on the Treatment of Soft Tissue Traumatic Injuries

Start date: May 30, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Soft tissue injuries are directly related to the energy of the trauma and its repair is the main factor for bone healing and the recovery of the function of the affected limb. Photobiomodulation (PBM) is indicated as an adjuvant treatment to accelerate wound healing, however, there is still a lack of evidence regarding its effect on traumatic soft tissue injuries. This project aims to evaluate the effects of the application of PBM in the resolution of complex soft tissue injuries of traumatic origin associated with tibial fractures. 84 adult individuals, aged between 18 and 60 years, hospitalized with tibial fractures awaiting resolution of soft tissue injuries will be included to undergo definitive surgery. The subjects will be randomized in two groups: PBM (treated with a device with 144 LED emitting diodes at wavelengths of 420, 660 and 850nm, 3J per point for 10 minutes) and Sham (simulation of the LED application, with a device with characteristics identical to that of the PBM group, for the same period of time). Subjects will be treated daily until release for surgery. The primary outcome will be the assessment of the wound healing process using the BATES-JENSEN scale. Secondary outcomes will be: pain intensity; consumption of analgesic drugs; serum evolution of inflammatory markers C-reactive protein and creatine kinase, measurement of the lesion area, time needed for release for definitive surgery, presence of infection, and the cost-effectiveness of PBM. The evaluations will be carried out before the beginning of the intervention and daily until the participant is considered ready for surgery (which will be considered the end of the experimental period). Data will be analyzed statistically considering a significance level of 5%.

NCT ID: NCT04177537 Completed - Back Pain Clinical Trials

Real-World Experience of Athletes Treated With SAM

Start date: October 1, 2015
Phase:
Study type: Observational

Low-intensity continuous ultrasound (LICUS) is an FDA-approved bio regenerative technology, applied with a wearable device (SAM, Zetroz Systems LLC) for daily use. The treatment provides long-duration ultrasound for approximately four hours. This report included a retrospective convenience sample of 6 athletes from one sports medicine and rehabilitation facility. The objective of this report is to examine the real-world outcome data on symptoms improvement and return to function using Sam. It was hypothesized that LICUS stimulation, in conjunction with traditional therapies, will accelerate the healing process of musculoskeletal tissue leading to a reduction in pain, increase functionality, and a higher probability of returning to work and sports-related activities. The sample included athletes with sports-related musculoskeletal injuries. Demographics, injury history, treatment history, and clinical outcomes data were retrospectively collected for athletes who were treated with SAM in conjunction with traditional therapies. Clinical results showed a benefit from the treatment with a decrease in pain (100%), and 3 out of 6 athletes were able to return to work or sports (50%). Overall the study shows that Sam accelerates the healing of soft tissue leading to a decrease in both acute and chronic pain.

NCT ID: NCT03880188 Enrolling by invitation - Wounds and Injuries Clinical Trials

Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds

FTFDT2
Start date: September 10, 2022
Phase:
Study type: Observational

This study will evaluate the use of free autologous dermal fat grafting (also called free dermal fat autografting) to treat complex craniofacial wounds that have failed standard treatment and to understand how well these grafts work to repair wounds long term. Patients who have undergone free autologous dermal fat grafting to treat complex craniofacial wounds 2-30 years ago will have photographs and small biopsies taken of the area that was grafted.

NCT ID: NCT03872544 Not yet recruiting - Wounds and Injuries Clinical Trials

Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds

FTFDT3
Start date: September 20, 2023
Phase:
Study type: Observational

This study will evaluate the use of free autologous dermal fat grafting (also called free dermal fat autografting) to treat complex craniofacial wounds that have failed standard treatment and to understand how well these grafts work to repair wounds long term. Patients who have undergone free autologous dermal fat grafting to treat complex craniofacial wounds less than 1 week ago will have photographs and small biopsies taken of the area that was grafted. Patients will be followed for 2 years to monitor the area that was grafted.