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Diabetic Foot Ulcer clinical trials

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NCT ID: NCT06383013 Recruiting - Diabetic Foot Ulcer Clinical Trials

Phase II Study of BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers

Start date: February 29, 2024
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and foot ulcer.

NCT ID: NCT06319287 Recruiting - Diabetic Foot Ulcer Clinical Trials

Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)

Start date: February 27, 2024
Phase: Phase 2
Study type: Interventional

A Phase 2a Multi-Center, Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects with Diabetic Foot Ulcers (DFU)

NCT ID: NCT06316115 Recruiting - Diabetic Foot Ulcer Clinical Trials

Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement

Start date: December 12, 2023
Phase: N/A
Study type: Interventional

Diabetic foot ulcer; It is a disease used to describe a series of lower extremity complications that may occur together with infection, ulceration or gangrene in individuals with diabetes and is coded as S91.3 and S91.8 in the International Classification of Diseases (ICD). Sharp debridement, one of the treatments for diabetic foot ulcers, is a short-term application performed with a sharp scalpel or scissors at the patient's bed or in outpatient clinic conditions. It should be performed by a skilled clinician with wound training. To our knowledge, no study has been found in the literature regarding the use of a stress ball as an intervention to prevent pain and anxiety during sharp debridement. In line with this information, this study will examine the effect of stress ball use on the pain and anxiety levels of patients with diabetic foot ulcers during wound debridement.

NCT ID: NCT06236750 Recruiting - Diabetic Foot Ulcer Clinical Trials

Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds

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

The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.

NCT ID: NCT06185465 Recruiting - Burns Clinical Trials

Effectiveness and Safety of Using Prontosan to Treat Bacterial Biofilm

Start date: January 3, 2024
Phase: N/A
Study type: Interventional

The goal of this prospective, multi-center, randomized, parallel-controlled, open-label clinical study is to evaluate the effectiveness and safety of Prontosan wound irrigation solution comparing with Normal Saline on the removal of wound bacterial biofilm through observing the morphological characteristics and development of bacterial biofilm in chronic wound patients with secondary infections. The main questions it aims to answer are: - Difference in scoring the positive rate of bacterial biofilm before the first treatment and on the 7th day of treatment in Group A and Group B - Difference in scoring the positive rate of bacterial biofilm before the first treatment and on the 3rd day of treatment in Group A and Group B . - Positive detection rate of bacterial biofilm in group and group B before the first treatment, and on the 3rd and 7th day of treatment, and difference of the positive detection rate of biofilm among the two groups. - 4-phase typing of bacterial biofilm detected in Group A, Group B and Group C before the first treatment, and on the 3rd and 7th day of treatment, and the proportion difference of 4-phase typing of biofilm among the two groups. - Wound healing rate - Skin Infection Rating Scale (SIRS) score. - Distribution of inflammatory cells on the wound. - Detection rate of bacteria/drug-resistant bacteria on the wound and their correlation with the detection rate of bacterial biofilm. Participants will be randomized to experimental group or Control group, Prontosan Wound Irrigation Solution or normal saline will be extracted with syringe (Dosage 1-2ml/cm2), and the wound is rinsed 1 cm from the wound. Then, Prontosan wound irrigation solution or normal saline is used to saturate the gauze, and the gauze is applied to the wound for 15 minutes. After removing the gauze, cover it with oil gauze, then cover it with 8 layers of gauze and wrap it with a bandage.

NCT ID: NCT06141811 Recruiting - Diabetic Foot Ulcer Clinical Trials

A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial

Start date: April 25, 2023
Phase:
Study type: Observational [Patient Registry]

This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-302) for 24 months

NCT ID: NCT06135987 Recruiting - Diabetic Foot Ulcer Clinical Trials

Clinical Evaluation in Real Life of TLC-NOSF Dressings in the Local Treatment of Chronic Wounds (DFU and VLU)

STARTLIFE
Start date: June 24, 2022
Phase:
Study type: Observational

The objective of this study is to document the performance and the safety of UrgoStart Plus® Border, UrgoStart Plus® Pad and UrgoStart Interface® in the local treatment of diabetic foot ulcers (neuropathic or neuroischemic - non-critical ischemia) and venous or mixed predominantly venous leg ulcers, in real life conditions and current practice, in France.

NCT ID: NCT06111183 Recruiting - Diabetic Foot Ulcer Clinical Trials

Evaluation of AUP12602-C as New Topical Treatment for DFUs (DIAMEND STUDY)

Start date: July 21, 2023
Phase: Phase 2
Study type: Interventional

This is a phase 2 study performed in diabetic foot ulcer (DFU) patients with chronic non-healing, neuro-ischemic wounds to investigate the safety, tolerability and efficacy of AUP1602-C.

NCT ID: NCT06104969 Recruiting - Diabetes Clinical Trials

DFC 004 Biomarkers for Active Diabetic Foot Ulcers

Start date: June 15, 2023
Phase:
Study type: Observational

This study is a platform study designed to efficiently test multiple biomarkers to identify diabetic foot ulcers (DFUs) with a higher potential for healing versus not healing that ultimately could be applied at the point of care to drive personalized management decisions, and to better inform clinical trials of wound healing interventions

NCT ID: NCT06037369 Recruiting - Diabetic Foot Ulcer Clinical Trials

The Short Message-based Customized Standardized

Start date: September 14, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to develop a short message-based customized standardized diabetic foot ulcer patient education program, and to test the effect of the program on diabetic foot ulcer self-management behavior, self-efficacy, wound prognosis, and quality of life. The short message-based customized standardized patient education program combines several smartphone message-based standardized educational contents to construct a customized patient education program which is according to the needs of patients, thus providing individualized patient education in a timely manner