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Diabetic Foot clinical trials

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NCT ID: NCT06262854 Not yet recruiting - Clinical trials for Surgical Procedure, Unspecified

Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study

BIG D-FOOT
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

This study is designed as a double-blind, placebo-controlled, parallel series randomized trial aimed at verifying the effiicacy and safety of a local calcium-sulphate bio-absorbable antibiotic delivery (tobramicina+vancomicina) versus placebo (calcium-sulphate matrix without antibiotics) in patients with diabetic foot osteomyelitis treated with surgical procedures.

NCT ID: NCT06232421 Not yet recruiting - Clinical trials for Chronic Venous Insufficiency

Clinical Study in Adult Patients With Purulent-inflammatory Processes of the Skin and Soft Tissues, Phase I-II of the Wound Process

OLENKRON-01
Start date: June 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to estimate efficiency, tolerance, safety of "Foscelantan, medicinal plate 4.0x5.0 cm in package No. 1" among adult patients who have purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome or chronic venous insufficiency, phase I-II of the wound process.

NCT ID: NCT06231771 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Safety and Efficacy of Stem Cells for Diabetic Foot Ulcer

Start date: May 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this clinical trial is to evaluate the effectiveness and safety of Wharton-Jelly mesenchymal stem cells administered around the ulcer site in patients with nonhealing diabetic foot ulcers. The key inquiries it seeks to address include the percentage of patients achieving complete healing/closure of the specified ulcer at any point during the 6-week period, the duration required for the complete closure of the target ulcer, and the nature and occurrence of adverse events (AEs), along with the total number of AEs and the proportion of patients experiencing AEs. Patients meeting the eligibility criteria will receive either allogeneic mesenchymal stromal cells (MSC) or a placebo. The peri-ulcer injection of umbilical cord MSC or placebo will be administered at multiple locations, around the ulcer. Subsequent follow-up after the administration of umbilical cord MSC or placebo will be conducted to monitor and observe the progress of ulcer healing.

NCT ID: NCT06227520 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Acellular Dermal Allograft for Chronic Diabetic Wounds

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

The purpose of this study is to determine the efficacy of a novel decellularized dermal matrix (DDM) DermGEN™ for the treatment of diabetic foot ulcers (DFU). Despite several advances in wound treatments, hard-to-heal wounds, such as diabetic foot ulcer, still require 12 to 16 weeks to achieve complete closure. Although the focus of most research into wound-healing treatments has been on moisture and bacterial control, new approaches that target the instability of the extracellular matrix (ECM) in a wound are timely and much needed, particularly for hard-to-heal wounds such as DFUs. Innovative technologies that provide ECM interactions halt the chronic inflammatory cycle and stimulate cells that allow for tissue regeneration and wound healing. DermGEN™ is a human dermal allograft that has been minimally processed from human skin to remove epidermal and dermal cells while preserving the structure and intrinsic properties of the natural extracellular matrix of the dermis. This has potential to facilitate a shorter wound-healing time.

NCT ID: NCT06197412 Not yet recruiting - Clinical trials for Diabetic Foot Ulcer Treatment

Multi-center Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot Ulcer

Start date: January 8, 2024
Phase: Phase 4
Study type: Interventional

Yunnan Baiyao has been treating all kinds of wounds for 120 years, but the evidence of Evidence-based medicine that is truly convincing is insufficient, making its best application method unclear. This study explored the possible indications and use methods of Yunnan Baiyao in different stages of Diabetic foot, and obtained Evidence-based medicine evidence of clinical efficacy. Obtain the discarded tissues of Diabetic foot patients in the treatment and control groups of Yunnan Baiyao after wound debridement, conduct Transcriptome (BulkRNA seq) analysis and detection on the wound tissues, and analyze the related signal pathways and functional genes with significant differences, to help clarify the possible treatment targets of Yunnan Baiyao.

NCT ID: NCT06189638 Not yet recruiting - Clinical trials for Diabetic Foot Ulcers

Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic Foot Ulcers

PL-5
Start date: January 8, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the clinical efficacy and safety of Antimicrobial Peptide PL-5 Topical Spray in patients with mild infections of diabetic foot ulcers. Eligible subjects will be randomized (1:1:1) to receive twice a day, 14 days treatment of Antimicrobial Peptide PL-5 Topical Spray (1‰), Antimicrobial Peptide PL-5 Topical Spray (2‰) and topical placebo (vehicle) spray. In this study, the cut-off date for final analysis is defined as the time when all subjects have completed the last visit or discontinued the study

NCT ID: NCT06150209 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

A Controlled Prospective Treatment Study to Evaluate the Efficacy of Vendaje.

Start date: January 15, 2024
Phase: N/A
Study type: Interventional

The Goal of this study is to evaluate the wound volume reduction rate and the time to closure when using Vendaje to manage diabetic wounds. The participants will be treated weekly for up to 12 weeks. The data will be compared to retrospective Standard of care data from similarly controlled studies

NCT ID: NCT06140303 Not yet recruiting - Diabetic Foot Clinical Trials

SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II)

Start date: February 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 diabetic foot ulcers.

NCT ID: NCT06137222 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Prospective, Multicenter, RCT of the Tenex Ultrasound System

Start date: December 4, 2023
Phase: N/A
Study type: Interventional

The goal of this multicenter randomized controlled trial is compare standard of care (SOC) to Tenex MicroTip ultrasound therapy plus SOC in patients with Wagner 1-2 diabetic foot ulcers. The main outcomes to answer are: Does the use of the TXB MicroTip plus SOC increase complete wound healing in Wagner 1-2 diabetic foot ulcer (DFUs) vs. SOC only at 12 weeks (end of treatment)? Does the use of the TXB MicroTip plus SOC increase complete wound healing in Wagner 1-2 DFUs vs. SOC over a subsequent to treatment 12 month follow-up? Participants will be asked to come in weekly over a 12 week period for treatment of the Wagner 1-2 DFUs til the DFU is healed. Those whose DFU has healed over the 12 week period will be assessed for durability of healing over a subsequent 12 month period (with assessments occurring monthly.

NCT ID: NCT06092827 Not yet recruiting - Physical Inactivity Clinical Trials

Feasibility and Acceptability of Non Weight-bearing Physical Activity for People With Diabetic Foot Ulceration

DB-ACTIV
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

Intervention in the form of a PA (physical activity) program combining aerobic, resistance, and flexibility exercises adapted for wearing a lower limb offloading device and limiting weight-bearing on the feet, with a duration of twelve (12) weeks, consisting of two supervised sessions and one unsupervised home session per week.