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NCT ID: NCT06000722 Completed - Diabetic Foot Ulcer Clinical Trials

SGLT-i Use in Diabetic Foot Ulcer Disease

Start date: December 5, 2023
Phase:
Study type: Observational

Background: People with diabetes and either current or previous diabetic foot ulcer disease (DFUD) are at very high risk for adverse cardiovascular events including heart attacks and strokes. Sodium-glucose co-transporter 2 (SGLT2) inhibitors are a class of medications that have shown to be very effective in reducing heart disease and event risk. However, one recent study found that SGLT2i's may increase minor amputation risk in those with DFUD, though this finding has not been replicated in other similar studies. However, as a result, there has been limited further investigation into this issue and as such the use of SGLT2i's in those with DFUD remains a contentious issue, despite their potential for significantly reducing cardiovascular disease risk in this population. In the absence of further randomised controlled trials investigating the use of SGLT2is in these populations, there is a need for clinical guidelines advising on their use based on expert clinical consensus, including specific criteria or scenarios in which they should or should not be used. The Delphi methodology is an iterative survey technique that uses expert opinion from various relevant backgrounds and experiences to generate a consensus based upon various statements and/or scenarios. Aim: The aim of this study is to use the Delphi technique to generate expert consensus-based clinical guidelines on the use of SGLT2i's in those with diabetes and DFUD. Methods: This is a Delphi technique-based study using a purposive sample of convenience. Consensus development methods will be used to generate clinical guidelines, endorsed by key clinical groups, on the use of SGLT2i's in patients with diabetic foot ulcer disease, including acknowledgement of specific scenarios or patient characteristics that may influence these guidelines. The consensus group will consist of n=20 healthcare practitioners, including GPs, secondary care diabetologists, foot care specialists, cardiologists and pharmacists in order to ensure a breadth of expertise and input. Two rounds of the Delphi consensus process will take place, in order to iteratively develop the consensus-based clinical guidelines. This process is expected to take 4-6 months. The analysis will be on-going throughout the study and completed within 3 months of the last questionnaire round of the Delphi process.

NCT ID: NCT05992142 Completed - Ulcerative Colitis Clinical Trials

ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA

CARUC-ASA
Start date: January 17, 2023
Phase: Phase 4
Study type: Interventional

For the last years the aim of the management of ulcerative colitis (UC) has become more ambitious including not only clinical remission but also the achievement of biological remission, endoscopic and histological healing, which are associated with less flares, hospitalizations and surgeries. About 50% of the patients with UC followed in routine are treated by 5-aminosalicylate acid (5-ASA) (oral and/or topical). The aim of the study is to describe the different levels of remission (clinical, endoscopic, histological) in UC patients treated only by 5-ASA, that report to be in clinical remission during a routine follow-up visit. The factors associated with different levels of remission (demographic, 5-ASA regimen, biologic, endoscopic, histologic) will be studied. Adherence and quality of life will be examined through patient questionnaires.

NCT ID: NCT05974982 Completed - Venous Leg Ulcer Clinical Trials

Treatment Outcome of Autologous PRP Versus Conventional Therapy Among Patients With Chronic Venous Leg Ulcers

Start date: September 1, 2022
Phase: Phase 1
Study type: Interventional

The use of PRP has dramatically increased in the fields of orthopedics, spine surgery, reconstructive plastic surgery, oral and maxillofacial surgery, and dermatological indications. Nonetheless, its use in the treatment of wounds is not as widespread as in other fields. In this experimental study, the treatment outcome of autologous PRP was assessed in comparison to conventional therapy among patients with chronic venous leg ulcers.

NCT ID: NCT05924893 Completed - Cornea Ulcer Clinical Trials

The Use of Naltrexone Hydrochloride to Promote Healing in Patients With Resistant Non-infectious Corneal Ulcer

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The opioid growth factor-receptor antagonist-naltrexone hydrochloride (NTX)- has gained much reach interest for applications in ophthalmology, because of its novel mechanism of action for speeding up corneal wound healing in both diabetics and non-diabetics, effective both locally and systemically and its availability as a low molecular weight synthetic drug.

NCT ID: NCT05908968 Completed - Clinical trials for Foot Ulcer, Diabetic

Assessing the Effects of ELO Water on Diabetic Foot Ulcers

Start date: September 19, 2017
Phase: N/A
Study type: Interventional

This pilot study examined the effects of ELO water, a commercially-available oxygen-enriched drinking water, on wound healing in patients with diabetic foot ulcers over 12 weeks.

NCT ID: NCT05892341 Completed - Diabetic Foot Clinical Trials

AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period

Start date: December 5, 2022
Phase: N/A
Study type: Interventional

Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing

NCT ID: NCT05883098 Completed - Diabetic Foot Clinical Trials

SDRM® vs. Collagen for Diabetic Foot Ulcers

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

Supra SDRM® is FDA-cleared as a dressing for treating partial and full-thickness wounds. It is a dermal substitute that provides a barrier and an ECM-like structure to help accelerate wound healing. SUPRA SDRM® has 510k approval for partial and full-thickness wounds and has shown promising results in preliminary animal studies. The purpose of this clinical evaluation is to collect and compare outcomes data from patients with UT 1A diabetic foot ulcers treated with a commercially available dermal substitute, Supra SDRM®, as compared to an advanced standard of care (Fibracol Plus). Patient outcomes, including time to heal, healing by 12 weeks, direct costs, and infection rate, will be compared at the end of the study.

NCT ID: NCT05849701 Completed - Clinical trials for Chronic Diabetic Foot Ulcer

Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer

Start date: March 10, 2022
Phase: N/A
Study type: Interventional

This study will be a randomized, open-label, pretest post-test with two study groups.

NCT ID: NCT05841394 Completed - Clinical trials for Stress Ulcer Bleeding

A Multi-center, Double-blinding, Parallel and Positive-controlled Phase III Clinical Trial for Efficacy and Safety Evaluation of Ilaprazole Sodium for Injection on Prevention of Stress Ulcer Bleeding

Start date: July 16, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of the study drug (Ilaprazole Sodium for Injection) for potential effect on preventing stress ulcer bleeding in vulnerable population by comparing the radio of upper gastrointestinal bleeding when they are administered Ilaprazole Sodium for Injection and Esomeprazole Sodium for Injection respectively.

NCT ID: NCT05797285 Completed - Diabetic Foot Ulcer Clinical Trials

Evaluating The Efficacy Of A Keratin Graft In Treating Non-Healing Diabetic Foot Ulcers

Start date: February 28, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical pilot is to collect patient outcome data on a commercially available, keratin-based skin substitute matrix: ProgenaMatrix®. In this trial, two groups of patients with diabetic foot ulcers (DFUs) will be randomized to receive treatment with ProgenaMatrix applied either weekly or bi-weekly to the target wound. Researchers will compare how weekly or bi-weekly application of ProgenaMatrix affects the healing of DFUs. The primary questions to be answered are: 1. How many patients achieve wound closure in 12 weeks with ProgenaMatrix treatment? And 2. What is the change in wound area during the trial in each group?