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Foot Ulcer clinical trials

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NCT ID: NCT06455475 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone

Start date: June 2024
Phase: N/A
Study type: Interventional

This randomized controlled study evaluates the adjuvant use of Derm-Maxx in patients with diabetic foot ulcers

NCT ID: NCT06453187 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers

Start date: June 30, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of hard-to-heal diabetic foot and venous leg ulcers.

NCT ID: NCT06449638 Not yet recruiting - Diabetic Foot Clinical Trials

Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs

CAMPSTIM
Start date: June 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.

NCT ID: NCT06444906 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

A Two-Part, Randomized Study of Dermacyte® Amniotic Wound Care Matrix

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

This is a multi-center, prospective, two-part, controlled study to determine the percentage of participants with complete ulcer closure of a target DFU at Week 12 following treatment with Dermacyte Matrix or SOC.

NCT ID: NCT06439667 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING

Tele-foot X
Start date: September 3, 2024
Phase:
Study type: Observational

The purpose of the study is design and use a telemedicine platform which integrates video-chat, pre-programmed interactive game-based foot, and ankle exercise modules, and real-time quantitative performance metrics displayed to the clinician to improve patient's perfusion to the lower extremity, improve diabetic wound healing and prevent muscle loss in the lower extremity.This is a cross sectional and comparative feasibility study. It is designed to explore acceptability, feasibility and proof of concept/ .

NCT ID: NCT06437028 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Evaluating the Efficacy of Perinatal Membrane Allografts for the Treatment of Diabetic Foot Ulcers.

Start date: September 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients. The main question that this study aims to answer is: Does the use of perinatal tissue allografts in conjunction with standard of care wound management techniques result in a higher percentage of patients achieving complete wound closure (i.e. healing) as compared to patients being treated with standard of care alone after 6 and 12 weeks of treatment. One ulcer on each participant's foot will receive weekly 1) applications of perinatal tissue allografts and standard of care wound management or 2) standard of care wound management alone. Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks. Additionally, the participants will be asked to fill out a questionnaire about the wound impacts their life.

NCT ID: NCT06420245 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management

REBOUND
Start date: June 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn if use of Orion TM, a dual-layer amniotic membrane allograft, in addition to standard wound care treatment can improve patient outcomes for people over the age of 50 with diabetic foot ulcers. The main question it aims to answer is the incidence of complete wound closure at the end of 12 weeks of treatment. Researchers will compare the outcomes between a group of people treated with standard wound care and another group treated with standard wound care in addition to the amniotic membrane allograft to see if the amniotic membrane allograft improves patient outcomes. Participants will visit their doctor weekly over a 12 week period, as per standard diabetic foot ulcer treatment procedures, and fill out a questionnaire measuring quality of life.

NCT ID: NCT06416462 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot

Start date: July 30, 2024
Phase: N/A
Study type: Interventional

Diabetic foot ulcer affects 10.5% of the Brazilian/world population, compromising the quality of life of these patients and burdening the public health system. Studies show that antimicrobial photodynamic therapy (aPDT) accelerates its repair, however, there is not enough evidence for decision-making in clinical practice, which prevents this treatment from being used on a large scale. Controlled and randomized clinical studies are needed to increase the level of evidence on this subject, promoting the improvement of the quality of life of people affected by diabetic foot ulcers. The aim of this study is to analyze the action of antimicrobial photodynamic therapy on the quality of the wound and tissue repair process using the Bates-Jensen scale in people affected by diabetic foot wounds.

NCT ID: NCT06402565 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers

NTCDU
Start date: May 15, 2024
Phase: Phase 1
Study type: Interventional

The goal of this multi-center, randomized, placebo-controlled, evaluator-blinded study is to assess the safety and efficacy of NOX1416 in the treatment of chronic, non-healing, diabetic foot ulcers (DFUs). Subjects will be randomized to receive treatment with NOX1416 or placebo, as an adjunct to Standard of Care (SOC). The primary objective of the study is to demonstrate the safety and tolerability of NOX1416 as adjunct to SOC. The secondary objective is to evaluate the clinical benefit of daily NOX1416, as an adjunct to standard of care SOC. Each site will assign a physician (or designee) to serve as the blinded evaluator who is responsible for assessing the study endpoints. The blinded evaluator will not be involved in the clinical care of subjects.

NCT ID: NCT06384183 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Kerecis Real World Registry

Start date: July 2024
Phase:
Study type: Observational [Patient Registry]

Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices