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Leg Ulcer clinical trials

View clinical trials related to Leg Ulcer.

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NCT ID: NCT05285930 Completed - Ulcer, Leg Clinical Trials

Effect of Bee Venom Phonophoresis on Healing of Chronic Lower Limb Ulcers

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

PURPOSE: to determine the impact of bee venom phonophoresis in accelerating ulcers healing. BACKGROUND: Bee venom (BV) phonophoresis has been suggested as a noninvasive treatment for a number of inflammatory conditions and in healing of ulcers. Ulceration due to vascular causes is often multifactorial and can be caused by both arterial and venous disease. Hypertension and atherosclerosis of the peripheral vessels lead to arterial disease associated with ischemic ulcers. Chronic venous insufficiency and the resulting venous hypertension cause venous ulcers. There are lack in knowledge and information in published studies about the efficacy of bee venom phonophoresis as physical therapy modality in accelerating ulcers healing. So, this study will be designed to provide a guideline about the efficacy of of bee venom phonophoresis in accelerating ulcers healing. HYPOTHESES: It will be hypothesized that: It was hypothesized that Bee venom phonophoresis has no or limited effect in accelerating ulcers healing. RESEARCH QUESTION: Does Bee venom phonophoresis an effect in accelerating ulcers healing?

NCT ID: NCT05158764 Completed - Venous Leg Ulcer Clinical Trials

Efficacy and Safety of URGOBD001 Compression System

FUTURE
Start date: December 3, 2021
Phase: N/A
Study type: Interventional

Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of the new URGO BD001 compression system versus a reference compression in the local treatment of venous or mixed predominantly venous leg ulcers: prospective multicenter, randomized controlled, open-label clinical study

NCT ID: NCT05148390 Completed - Diabetic Foot Ulcer Clinical Trials

Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice

GELFI
Start date: April 24, 2022
Phase:
Study type: Observational

This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e. within its intended purpose and without any additional invasive or stressing examinations for the patients. Up to 36 adult patients with wounds suitable to be treated with the medical device and meeting the inclusion/exclusion criteria will be enrolled at two participating German sites. During 5 on-site visits within 28 days routine weekly dressing changes the Health Care Professional will examine the wound and will perform required wound care and dressing changes. Pictures of the wound with and without dressing will be taken at each visit and used for automatic analysis. The subjects will be asked to rate their general wound pain and the pain perceived during dressing changes. A wound-related quality of life questionnaire will be presented to the subjects twice and the subject and HCP will rate their safisfaction with the product.

NCT ID: NCT04956900 Completed - Venous Leg Ulcer Clinical Trials

Clinical Trial Enzyme Application Targeting Venous Leg Ulcers

CLEANVLU
Start date: August 9, 2021
Phase: Phase 2
Study type: Interventional

This is an adaptive open-label, first-in-human (Phase IIa) study designed to assess the safety (and efficacy) of Aurase Wound Gel, an enzymatic debridement product, intended for topical application to sloughy venous leg ulcers (VLU)

NCT ID: NCT04829812 Completed - Clinical trials for Peripheral Arterial Disease

Medical Compression in Patients With Chronic Wound and Peripheral Arterial Disease

COMPAD2
Start date: March 15, 2021
Phase:
Study type: Observational

Real-life practice survey of vascular specialist in France caring for patients with chronic wound for which compression treatment would be indicated and arterial disease of the lower limbs

NCT ID: NCT04817228 Completed - Diabetic Foot Ulcer Clinical Trials

A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers

Start date: April 21, 2021
Phase: Phase 2
Study type: Interventional

This study will be a multicenter, prospective, open label, one-arm study intended to assess the clinical performance and safety of EX-02 in debridement of lower leg ulcers: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcer (DFU). In addition, the pharmacology effect of EX-02 will be assessed. Lower leg ulcer size between 2 cm2 and 80 cm2 (surface area).

NCT ID: NCT04753294 Completed - Diabetic Foot Ulcer Clinical Trials

Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems

ASOLO-CW
Start date: June 14, 2021
Phase: N/A
Study type: Interventional

The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in accordance with the Instructions for Use, for up to 28 days.

NCT ID: NCT04714749 Completed - Venous Leg Ulcer Clinical Trials

Feasibility and Tolerance Study for the Treatment of Varicose Ulcers by Cyanoacrylate Glue (ETUVVE)

ETUVVE
Start date: January 21, 2021
Phase: N/A
Study type: Interventional

Ulcers of the lower limbs are a major public health problem whose management needs to be further improved, particularly in terms of healing time, prevalence and recurrence rate. Ulcers of venous origin, or mixed arteriovenous and predominantly venous, represent the majority of leg ulcers with an estimated proportion of 70 to 80% of cases. These are painful, disabling conditions that are difficult to treat in a lasting way. This study focuses on a treatment strategy with endovascular glue. The advantage of treating ulcers with cyanoacrylate glue is the possibility of occluding the great saphenous vein over its entire length, freeing itself from neurological complications secondary to endovenous thermal techniques (laser, radiofrequency), as well as the possibility of treating by direct puncture any perforators or tributaries feeding the ulcer. This treatment strategy would improve the healing process for a lasting resolution of this pathology. This study aims to describe the feasibility and tolerance of this type of treatment in the resolution of varicose ulcers.

NCT ID: NCT04577183 Completed - Diabetic Foot Ulcer Clinical Trials

A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing Wounds in Elderly Population in Specialized Nursing Facilities Using RD1

Start date: July 11, 2018
Phase: N/A
Study type: Interventional

The study is a prospective, single arm, multicenter efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss of these subjects). The subjects will receive up to 16 RD1 applications. In case of complete healing, subject will be called for one confirmatory visit two weeks later or before discharge from the SNF (the earlier of the two). Subject data will be kept in each site's records. All diabetic subjects' glycemic management will be performed by a qualified physician. All subjects will have wound care specialist or wound surgeon or dermatologist involved in their wound care

NCT ID: NCT04479618 Completed - Clinical trials for Sickle Cell Leg Ulcer

Test of the Safety, Effectiveness, & Acceptability of An Improvised Dressing for Sickle Cell Leg Ulcers in the Tropics

SCLUJamaica
Start date: July 6, 2021
Phase: N/A
Study type: Interventional

One in 300 Jamaicans have HbSS sickle cell disease, and of these, up to 70% will suffer from sickle cell leg ulcers (SCLUs). Of these, 24% will have a chronic SCLU (one lasting longer than 6 months). SCLUs heal very slowly, and sometimes they never close. SCLU patients would benefit from an economical, less painful, dressing option. In addition, because SCLUs often compromise education and employment opportunities, improving wound care for this population benefits their entire community. This three-armed evaluator-blinded randomized controlled trial will determine if a cut-to-fit food-grade plastic-based improvised dressing decreases pain, improves quality of life, and is safe, effective, and acceptable for managing SCLUs in Jamaica. The negative control will be usual practice, and the positive control will be the advanced wound dressing with the strongest evidence supporting its use in a tropical climate (polymeric membrane dressing). Patients with SCLUs will be actively recruited from three adjacent parishes. The first 120 SCLU patients meeting study criteria presenting to UHWI, Mona, will be randomized immediately after initial cleansing/debriding into group (1) current usual practice, group (2) improvised dressings, or group (3) advanced dressings. Data will be added to each participant's data collection tool weekly. Results will be reported using descriptive statistics and ANCOVA. The expected outcome is both improvised and advanced dressing superiority to usual practice. Because proposed improvised dressing materials are easily obtainable, their use would increase the capacity of wound patients to safely and effectively care for themselves. Signed informed consent will be obtained from patients/parents. Only principal research investigators will have access to participant confidential information. The literature review demonstrates that risks are not higher than usual practice.