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Foot Ulcer clinical trials

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NCT ID: NCT06403605 Recruiting - Diabetic Foot Ulcer Clinical Trials

Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

BGWM
Start date: August 29, 2022
Phase: N/A
Study type: Interventional

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available SOC treatments for Diabetic Foot Wounds.

NCT ID: NCT06402565 Recruiting - Diabetic Foot Ulcer Clinical Trials

NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers

NTCDU
Start date: May 23, 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: NCT06395961 Enrolling by invitation - Diabetic Foot Ulcer Clinical Trials

Effect of New High Ankle Block on Wound Healing After the Operation of Debridement of Diabetes Foot

Start date: August 2, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare high ankle block and general anesthesia on wound recovery and ankle blood flow perfusion after diabetes foot surgery in diabetics. The main questions it aims to answer are: - weather the high ankle block can fast wound recovery after the surgery - weather the high ankle block can improve ankle blood flow perfusion after the surgery Participants will receive either high ankle block or general anesthesia during surgery. After the operation, foot ulcer area and pulse perfusion index will be measured on the postoperative day of 1 and 14; lower limb hemodynamic parameters will be measured by ultrasound on the postoperative days of 1, 7, and 14. Researchers will compare high ankle block and general anesthesia to see if they have the different on the wound recovery and blood flow perfusion of the patients' foot.

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

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: 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: NCT06358846 Not yet recruiting - Diabetic Foot Clinical Trials

Effectiveness of Educational Intervention on Footcare Among Individuals Having Type 2 Diabetes at Slums of Karachi, Pakistan.

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

There are multiple studies conducted in Pakistan that supports the topic of foot care knowledge among individual with type 2 diabetes but all are descriptive cross-sectional studies and investigators cannot develop cause effect relationship out of it. Secondly, there is a lack of documented research on the foot care knowledge shown by people with T2D residing in the slums of Karachi. In order to assess the knowledge intervention among the individual having T2D through qualified diabetes educators and pictorial educational pamphlet along with the standard care of treatment. Consequently, it may aid in the development of effective methods aimed at mitigating foot-related complications among this specific population. Individuals diagnosed with diabetes are required to engage in proactive and structured self-care activities by providing the foot care knowledge in order to effectively manage their condition and mitigate the risk of potential complications. The incorporation of health-deviation knowledge and activities into routine is crucial.

NCT ID: NCT06328010 Enrolling by invitation - Burns Clinical Trials

An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care in Medical Centers

SIDDX
Start date: April 1, 2024
Phase:
Study type: Observational [Patient Registry]

Collect data on various wound treatments and their related wound healing process, in real life settings. Analyze the safety and efficacy of wound treatments, including: advanced biological/synthetic grafts and standard of wound care treatments.

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.