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Foot Ulcer clinical trials

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NCT ID: NCT06373809 Completed - Diabetic Foot Ulcer Clinical Trials

Placenta Derived Stem Cells for Treating of Chronic Ulcers and Neuropathy

PDSC
Start date: October 8, 2021
Phase: Early Phase 1
Study type: Interventional

This is an initial dose escalation safety and exploratory efficacy study to treat two groups of subjects with critically sized diabetic wounds and diabetic neuropathy using placental-derived stem cells (PDSC) transplanted by injection into soft tissues of the lower limb. Its primary objective is safety assessment and its secondary objective is determining optimum PDSC safe dose. Group 1 will receive implantation of cells in the ulcer, in the ulcer bed, and along the distal arterial vessels that supply blood to the foot. Group 2 will follow the same protocol for the foot but will have an additional dose of cells implanted in the anterior and posterior compartments of the same leg to determine the impact on peripheral neuropathy. Dose escalation and safety will be documented. Exploratory measures of efficacy include: ulcer healing, hemodynamic and anatomical effects on the arteries of the foot, and changes in the sensory perceptions of the foot.

NCT ID: NCT06067022 Completed - Diabetic Foot Ulcer Clinical Trials

Temporomandibular Dysfunction in Patients With Diabetic Foot Ulcers

Start date: January 5, 2023
Phase:
Study type: Observational [Patient Registry]

The aim of this observational study is to investigate the effects of the type, area and duration of ulceration on jaw pain, mandibular function limitation, TMD and swallowing in individuals with diabetic foot ulcers.The main questions it aims to answer are: - Does the change in foot structure due to diabetic foot ulcer have an effect on the temporomandibular jointand swalloving? - What are the determinants of tempomandibular dysfunction in individuals with diabetic foot ulcers? Participants (both groups) will be evaluated for quality of life, jaw functionality, mandibular dysfunction, oropharyngeal swallowing disorder, pain and diabetes complications.

NCT ID: NCT06065488 Completed - Foot Ulcer Clinical Trials

Functional Ankle Taping Correction on Plantar Foot Ulcer Healing in Diabetic Patients

Start date: October 6, 2023
Phase: N/A
Study type: Interventional

This study will investigate the effects of Functional ankle taping correction on plantar foot ulcer healing in diabetic patients. This study will be carried out at the outpatient clinic of the faculty of physical therapy, modern university for technology and information, Om El masryeen general Hospital and El Rahma - private clinic. All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.

NCT ID: NCT06000371 Completed - Diabetic Foot Clinical Trials

Cutoff Value of Ankle Brachial Pressure Index for Vacuum Assisted Closure Application in Diabetic Foot Ulcers

Start date: April 25, 2020
Phase:
Study type: Observational

Abstract Objective To verify cutoff value of ankle brachial pressure index at which diabetic foot ulcers get benefit from vacuum assisted closure application and to assess impact of its application on ankle brachial pressure index value in the presence of peripheral arterial disease. Methods An observational descriptive prospective analytic study had been performed.56 patients were enrolled in the study. All patients had three sessions of vacuum-assisted closure application. Debridement was done when indicated. Ulcer dimensions were measured before and after each session, while ankle brachial pressure index was measured before the first session .

NCT ID: NCT05908968 Completed - Clinical trials for Foot Ulcer, Diabetic

Assessing the Effects of ELO Water on Diabetic Foot Ulcers

Start date: September 19, 2017
Phase: N/A
Study type: Interventional

This pilot study examined the effects of ELO water, a commercially-available oxygen-enriched drinking water, on wound healing in patients with diabetic foot ulcers over 12 weeks.

NCT ID: NCT05883098 Completed - Diabetic Foot Clinical Trials

SDRM® vs. Collagen for Diabetic Foot Ulcers

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Supra SDRM® is FDA-cleared as a dressing for treating partial and full-thickness wounds. It is a dermal substitute that provides a barrier and an ECM-like structure to help accelerate wound healing. SUPRA SDRM® has 510k approval for partial and full-thickness wounds and has shown promising results in preliminary animal studies. The purpose of this clinical evaluation is to collect and compare outcomes data from patients with UT 1A diabetic foot ulcers treated with a commercially available dermal substitute, Supra SDRM®, as compared to an advanced standard of care (Fibracol Plus). Patient outcomes, including time to heal, healing by 12 weeks, direct costs, and infection rate, will be compared at the end of the study.

NCT ID: NCT05849701 Completed - Clinical trials for Chronic Diabetic Foot Ulcer

Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer

Start date: March 10, 2022
Phase: N/A
Study type: Interventional

This study will be a randomized, open-label, pretest post-test with two study groups.

NCT ID: NCT05797285 Completed - Diabetic Foot Ulcer Clinical Trials

Evaluating The Efficacy Of A Keratin Graft In Treating Non-Healing Diabetic Foot Ulcers

Start date: February 28, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical pilot is to collect patient outcome data on a commercially available, keratin-based skin substitute matrix: ProgenaMatrix®. In this trial, two groups of patients with diabetic foot ulcers (DFUs) will be randomized to receive treatment with ProgenaMatrix applied either weekly or bi-weekly to the target wound. Researchers will compare how weekly or bi-weekly application of ProgenaMatrix affects the healing of DFUs. The primary questions to be answered are: 1. How many patients achieve wound closure in 12 weeks with ProgenaMatrix treatment? And 2. What is the change in wound area during the trial in each group?

NCT ID: NCT05786612 Completed - Diabetic Foot Ulcer Clinical Trials

A Clinical Investigation Comparing the Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With SoC

BISIL
Start date: January 30, 2023
Phase: N/A
Study type: Interventional

A randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study) This study (BISIL) will compare the Biatain® Silicone dressing to commonly used wound care products (AQUACEL®EXTRATM Hydrofiber® Dressing used with Mepilex® Border). The study will recruit in total 100 adult subjects with a venous leg ulcer or a diabetic foot ulcer no deeper than 2cm. Only ulcers with a duration of at least 8 weeks but no longer than a year will be included. The study will be a randomised controlled trial where half of the participants will use Biatain® Silicone and half will use the comparator for 4 weeks. Each participant will be in the study for 4-5 weeks during which there will be a weekly visit with the study team to complete the study assessments and change the dressing. The study will run for approximately one year, starting in January 2023.

NCT ID: NCT05747872 Completed - Clinical trials for Diabetic Foot Ulcers

Effectiveness of Buerger Allen Exercise Among Type 2 Diabetes Mellitus Patients With Foot Ulcer

Start date: March 10, 2022
Phase: N/A
Study type: Interventional

This study was conducted to determine the effect of Buerger Allen exercises on lower extremity perfusion and wound healing in patients with foot ulcer type 2 diabetes. The Buerger Allen exercise is a specific exercise that aims to improve circulation in the feet and legs. Buerger Allen exercise is an ideal and noninvasive therapy for diabetic patients with a diabetic foot ulcer as it is an easy-to-learn, repetitive, low-cost, and low-risk physical activity. Subjects were randomly allocated to either the control or intervention group. The ulcers and lower extremity perfusion of the patients in both the intervention and control groups were examined and measured.