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Skin Ulcer clinical trials

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NCT ID: NCT06281483 Recruiting - Clinical trials for Chronic Non-healing Skin Ulcers

PRP Versus PRF Versus Conventional Treatment in Chronic Non-healing Skin Ulcers

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

To compare the therapeutic efficacy of PRP and PRF: two relatively newer modalities in the management of chronic non-healing ulcers versus conventional treatment.

NCT ID: NCT05764876 Recruiting - Yaws Clinical Trials

Repurposing Clinically Approved Drugs for Yaws With an Insight Into the Cutaneous Ulcer Disease Syndrome (Trep-AByaws)

Trep-AByaws
Start date: March 14, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to test the non inferiority of linezolid compared with azithromycin as a treatment for yaws . The main questions it aims to answer are: can linezolid cure active yaws, and can linezolid cure latent yaws. Participants with serologically confirmed yaws will be randomized to receive linezolid (experimental) or azithromycin (control group) treatment and followed up to assess clinical resolution.

NCT ID: NCT05243368 Recruiting - Foot, Diabetic Clinical Trials

Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics

Start date: October 20, 2023
Phase: N/A
Study type: Interventional

The ageing population and the increase in diabetes raise the prevalence of chronic skin ulcers (CCU). In diabetics, precursor cell mobilization decreases. In wounds, the inflammation is prolonged and oxidative stress increases. This is an unfavorable microenvironment for healing. A major risk factor in the development of CCU is nutritional deficiency. Healing needs energy and nutrients for regeneration. In diabetics the malnutrition can be more than 60%. However, although the provision of certain nutrients can improve the healing capacity, it is not a common clinical practice to nutritionally evaluate diabetic with CCU. Exosomes are extracellular vesicles that reflect the physiological state of the cells producing them. Stem cell derivatives exosomes are rich in factors, that can provide a favorable microenvironment for tissue regeneration. The aim of this project is to develop a therapeutic process to accelerate the healing of diabetic CCU, based on the correction of nutritional deficiencies, to improve the regenerative capacity, together with the application of exosomes from mesenchymal stem-cell (MSC) in the wound, creating a microenvironment that favors tissue regeneration. For this, a pilot clinical trial with diabetic patients with CCU is proposed, to evaluate the effect of personalized nutritional supplementation on healing and regenerative capacity.

NCT ID: NCT05204784 Recruiting - Systemic Sclerosis Clinical Trials

Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis

RHEACT
Start date: February 28, 2022
Phase: N/A
Study type: Interventional

In this feasibility study, we aim to explore therapeutic Rheopheresis (RheoP) as a novel treatment option for SSc-associated Raynaud's phenomenon and/or digital ulcers and compare it to the standard of care treatment (intravenous iloprost. RheoP has been used for RP/DU with some success in observational studies, nevertheless, the optimal treatment modality, duration, or frequency of RheoP (and PEX in general) in SSc has not been established as of yet.

NCT ID: NCT05181644 Recruiting - Scleroderma Clinical Trials

Effectiveness of the EmoLED Medical Device in the Healing of Digital Ulcers in Patients With Scleroderma.

SUITABLE
Start date: April 22, 2022
Phase: N/A
Study type: Interventional

The present clinical study aims to compare, in the two groups of patients with acral ulcers, the reparative process of the injured area, the evaluation of the healing time (with "healing" interpreted as the complete re-epithelization of the wound) and the perception of pain through NRS scale.

NCT ID: NCT05168215 Recruiting - Autoimmune Diseases Clinical Trials

Effectiveness of Bosentan Therapy in Patients With Systemic scleRosis and Progressive Digital ulcEr Disease.

CURE
Start date: January 1, 2022
Phase:
Study type: Observational

Digital Ulcers (DEs), are painful open sores on the fingers and toes and are due to limited perfusion of blood vessels in patients with Scleroderma. In particular, ulcers are caused by narrowing of the arteries, resulting in reduced blood supply to the fingers, causing pain and difficult to heal leaving deep scars. DEs may be present on the rails or fingertips, on the extensor surfaces of the joints, and depending on the underlying calcification. The etiology of ulcers is multifactorial. Raynaud's ischemia, sclerosis, dry skin, calcification and local trauma can all contribute to the onset of Digital Ulcers. Spontaneous fissures or ruptures can also develop into ulcers in patients with scleroderma and severe Raynaud's disease. Whatever the reason for their appearance, DEs negatively affect the quality of life of patients as they complicate even simple daily activities, while they can lead to serious complications such as osteomyelitis or other serious soft tissue infections, up to amputation. Over the last decade, in several randomized clinical trials, DEs have been studied in detail, which are defined or classified differently in each case. The clinical treatment of patients with DE would be facilitated by the availability of specific criteria for the classification of DE. Internationally, the classification of pressure ulcers is usually followed, but this classification is not sufficient for all types of DE observed in Scleroderma. The lack of a clear classification of DEs prompted researchers to evaluate the frequency and morphology of lesions, their characteristics, their physical course, and their healing time in groups of patients with Scleroderma. In a recent study, three categories of classification of digital ulcers based on the patient's clinical picture were proposed by the UK Scleroderma Study Group (UKSSG).

NCT ID: NCT05165628 Recruiting - Diabetic Foot Ulcer Clinical Trials

Safety, Tolerability and Efficacy of CYP-006TK in Adults With Diabetic Foot Ulcers

Start date: January 4, 2022
Phase: Phase 1
Study type: Interventional

Design: A randomised, controlled, prospective trial. Participants will be patients with non-healing diabetic foot ulcers. The study will aim to recruit 15 participants per study group (30 participants in total). Participants will be randomly allocated to one of two treatment groups: - Group 1: CYP-006TK - Group 2: Standard care This will be an open label study with respect to treatment allocation. However, the person reviewing images of the study ulcers to assess healing will be blind to the participant's treatment allocation. Participants assigned to Group 1 will be treated with CYP-0006TK dressings on 8 occasions over 4 weeks. The dressings will be changed every 3 or 4 days. After the first 4 weeks, participants in Group 1 will revert to standard care for the rest of the study. Participants assigned to Group 2 will have their ulcer treated with standard care throughout the study. Participants will attend a total of 16 scheduled visits over 24 weeks. There will be a mixture of on-site (hospital/clinic) visits, and home visits. The study will end 24 weeks after the initiation of treatment, unless the study ulcer is completely headed before then.

NCT ID: NCT04971161 Recruiting - Clinical trials for Skin Ulcer Venous Stasis Chronic

Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of CVU (Phase IIb)

Start date: August 18, 2021
Phase: Phase 2
Study type: Interventional

The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction of CVUs) and safety (by monitoring adverse events [AEs]) of three dose groups of the investigational medicinal product (IMP) allo-APZ2-CVU, topically administered on target wounds of patients with CVU compared to placebo.

NCT ID: NCT04901325 Recruiting - Wound Heal Clinical Trials

Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG)

Start date: October 2023
Phase: Phase 2
Study type: Interventional

An Open-Label, Proof-Of-Concept, Study of Baricitinib for the Treatment of Pyoderma Gangrenosum

NCT ID: NCT04689243 Recruiting - Skin Ulcer Clinical Trials

Low Concentration ALA-PDT in Treatment of Skin Ulcer

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Skin ulcer is a common disease with complicated etiopathogenes, which makes it hard to be cured. It has been reported that photodynamic therapy (PDT) can be used to treat skin ulcers which were caused by different diseases. However, PDT is an expensive treatment and patients always experience obvious pain during or after the treatment, which hinders the application of PDT in skin ulcer. Our previous study found that PDT using a low concentration of 5-Aminolevulinic acid (ALA) could promote the healing of skin ulcer without obvious adverse reactions, which suggests us that low concentration ALA-PDT might be an efficient and cost effective treatment in skin ulcer. To further investigate the use of low concentration ALA-PDT in skin ulcer, we plan to recruit patients with skin ulcers caused by different diseases, and divide these patients into different groups according to their causes of disease, and then treat them using low concentration ALA-PDT to observe the healing process of skin ulcer. This study could further optimize and promote the use of low concentration ALA-PDT in skin ulcer.