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Foot Ulcer clinical trials

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NCT ID: NCT05610865 Recruiting - Diabetes Mellitus Clinical Trials

Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers

Start date: November 20, 2020
Phase: Phase 1
Study type: Interventional

The aim of this study is to evaluate the therapeutic efficacy of uncultured adipose derived stromal vascular fraction (SVF) and cultured adipose derived stem cells (ASCs) both supplemented with platelet rich plasma (PRP) to treat chronic diabetic foot ulcers. It will increase the pragmatic potential of both types of cells as PRP is rich in survival and chemotactic factors. Moreover, the autologous nature of the proposed study will ensure safety of its use in diabetic patients and will unveil the more effective therapeutic option for treatment of foot ulcer wounds.

NCT ID: NCT05608187 Recruiting - Diabetic Foot Ulcer Clinical Trials

Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers

Start date: September 26, 2022
Phase: Phase 2
Study type: Interventional

A randomized, double-blind, placebo-controlled, parallel, exploratory phase 2a study to evaluate safety and biologic efficacy on wound healing of ILP100-Topical in subjects with diabetic foot ulcers during 26 weeks with a 5-year long-term follow-up period. A total of 30 subjects will be randomized to low dose of ILP100-Topical (ILP100Lo), high dose of ILP100-Topical (ILP100Hi) or Placebo according to a 1:1:1 randomization schedule. The study will consist of a 3-weeks Screening and Run-in Phase, followed by a 5-week Treatment Phase starting from Baseline and an Assessment Phase from Week 5 to Week 26. Thereafter, the subjects will be followed yearly during 5 years in a Long-Term Safety Follow-up Phase.

NCT ID: NCT05607979 Recruiting - Diabetic Foot Ulcer Clinical Trials

Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds

RENEW
Start date: December 15, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This is an IRB-approved multicenter study.This non-inferiority study aims to evaluate differential healing rates between Lavior Diabetic Wound Gel and other Hydrogels. Study therapy will be started in the outpatient setting and followed accordingly.

NCT ID: NCT05603273 Recruiting - Type2diabetes Clinical Trials

Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers

Start date: December 13, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to improve the therapeutic management of diabetic foot ulcers (DFU). The main questions to answer are if a program of non-weight bearing exercise helps the DFU heal faster than standard wound care. This randomized clinical trial will determine how blood flow to the ulcer and whole body metabolism may be improved with exercise. Participants will be randomized to either exercise + standard wound care or standard wound care alone and undergo testing for leg blood flow, fitness and measures of metabolism through blood draws. The intervention period is 6-weeks. Eligible participants must have an existing foot ulcer uncomplicated by infection and be medically cleared to exercise.

NCT ID: NCT05595681 Recruiting - Diabetic Foot Ulcer Clinical Trials

Effect of Mesenchymal Stem Cells on Healing of Foot Ulcers in Diabetes Patients.

STEMFOOT
Start date: December 15, 2022
Phase: Phase 1
Study type: Interventional

The STEMFOOT Pilot Study is a single center randomized open phase I clinical intervention pilot trial with the aim of investigating the treatment effect of an allogenic adipose-derived mesenchymal stromal cell product (C2C_ASC) compared to conventional optimal treatment on healing and complications of foot ulcers in diabetes patients.

NCT ID: NCT05588583 Recruiting - Diabetic Foot Ulcer Clinical Trials

A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.

Start date: October 31, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit. Participants will be asked to wear Mepilex Up dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.

NCT ID: NCT05586542 Recruiting - Clinical trials for Foot Ulcer, Diabetic

Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers

Start date: October 3, 2022
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to determine the safety of DERMASEAL for the treatment of non-healing, neuropathic diabetic foot ulcers. The main outcome measure is safety. A total of twenty-four (24) participants will be randomized to receive up to four (4) consecutive weeks of treatment with either standard of care (SOC), plasma film + SOC, or plasma film containing silver microparticles (DERMASEAL) + SOC, with a final follow-up visit 12 weeks after the last treatment.

NCT ID: NCT05579743 Recruiting - Diabetic Foot Ulcer Clinical Trials

Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers

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

This research is being done to compare two different methods of wound monitoring for chronic wounds: remote wound monitoring using a smartphone app and in-person wound monitoring in a clinic setting. This will be a pilot non-blinded randomized controlled feasibility trial. The investigators will enroll 120 patients with an active diabetic foot ulcer (DFU) who present to the multidisciplinary diabetic foot clinic in Baltimore, Maryland. Patients will be computer randomized 1:1 to receive wound care monitoring using remote DFU monitoring technology or standard in-person monitoring for 12 weeks.

NCT ID: NCT05577104 Recruiting - Diabetic Foot Clinical Trials

Wound Bed Preparation for Diabetic Foot Ulcers

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

The study objective was to compare the efficacy of NPWT versus alginates dressings on the wound bed preparation prior to STSG surgery, as well as investigating the underlying mechanisms.

NCT ID: NCT05570877 Recruiting - Diabetic Foot Ulcer Clinical Trials

ChitoCare Medical Wound Healing Gel PMCF Study on Healing of Chronic Wounds

CHITOCHRONIC
Start date: January 11, 2022
Phase: N/A
Study type: Interventional

The purpose of this PMCF study is to evaluate the safety and efficacy of ChitoCare medical Wound Healing Gel for the healing of chronic wounds. The study will enroll patients with diabetic foot ulcer, venous ulcer or pressure ulcer. Patients will be randomly assigned to an active or control group. The active group will apply the gel to the wound, in addition to the standard of care, while the control group will receive only standard care. The study will last from 3 to 18 months for an individual patient (15-month recruitment period and 3 months of follow-up after the last patient is enrolled) or until event occurrence (complete wound healing/exclusion from the study). The study envisages four visits: Visit 1 - Screening and Inclusion visit, Visit 2 (after 4 weeks), Visit 3 (after 12 weeks) and Visit 4 - End of Study Visit: The final visit will take place when the event occurs (complete healing/exclusion from study). On each visit, the patients will have their wound photographed and assessed after debridement. Adverse events will be followed throughout the whole study.