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Varicose Ulcer clinical trials

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NCT ID: NCT04758728 Completed - Venous Reflux Clinical Trials

Adrenaline Reduces Ecchymoses and Hematomas and Improves Quality of Life After Classic Saphenous Vein Stripping

ARESQOLSAVES
Start date: September 10, 2015
Phase: N/A
Study type: Interventional

Aim of the present study is to investigate the efficiency of adrenaline (epinephrine) used locally in reducing and avoiding post-operative formation of subcutaneous ecchymoses and hematomas, in comparison with traditional practice of hemostasis, and to assess improvement in the quality of life of subjects undergoing classic great saphenous vein stripping, who received or did not receive adrenaline as a local hemostatic.

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: NCT04703569 Completed - Venous Ulcers Clinical Trials

Effect of Compressive Therapies on the Healing of Venous Ulcers

VENOS
Start date: December 2, 2020
Phase: N/A
Study type: Interventional

The objective of the study is to compare the effect of two treatments on the healing of venous ulcers in follow-up people in two Primary Health Services, in a city in southern Brazil. The two treatments that will be tested are: (1) the high compression elastic bandage and (2) Unna boot. The two treatments are indicated for the treatment of people with venous insufficiency and who have an active ulcer. The treatment will last 26 weeks (6 months). Once a week, during 26 weeks, a nurse will perform the dressing and will apply the therapy high compression elastic bandage or Unna boot according to a drawing and in every two weeks an evaluator will assess the characteristics of the ulcers and the size.

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: NCT04461132 Completed - Venous Leg Ulcer Clinical Trials

The Effect of Manual Lymphatic Drainage

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

In venous ulcer, venous insufficiency is accompanied by lymphatic insufficiency. Manual lymphatic drainage (mld) technique cause to increase contraction rate of lymphatic collector and venous flow. It is known that Manual lymphatic drainage accelerates microcirculation, enabling nutrients and oxygen to reach tissues and at the same time removing residual substances from the tissue. We hypothesis that if we inrease to lypmhatic activity with MLD, we could stimulate healing of ulcer. The aim of this study to investigate the effect of manual lymphatic drainage on venous ulcer healing.

NCT ID: NCT04310280 Completed - Wound Healing Clinical Trials

Effects of Local Insulin on Varicose Ulcers for Wound Healing

Start date: June 1, 2019
Phase: Phase 3
Study type: Interventional

A randomized, split-plot, double-blind, placebo-controlled trial. The varicose ulcer is divided into two (side A and B). Half of the wound's surface is treated locally with insulin (Glargine) applied at an approx depth of 3-4 mm. Treatment with insulin is administered for 7 days. Biopsy specimens of the two sides are obtained on days 0 and 7. A thermographic photograph of the wound is taken at days 0 and 7. The number of blood vessels and fibroplasia is evaluated as the main outcome.

NCT ID: NCT04280679 Completed - Varicose Veins Clinical Trials

Treatment of Insufficient Superficial and Perforatring Veins of the Lower Limb Using HIFU

Start date: March 3, 2020
Phase: N/A
Study type: Interventional

This is a one-arm, open label, prospective, single center study to evaluate clinical standardization with Theraclion's Sonovein 2 HIFU device. The original Sonovein device was tested in a clinical trial in 50 subjects and received CE Mark. That device has been updated yielding the current version of Sonovein 2. Based on the technical similarities between both devices in term of design, performance and principle of operation, the clinical data for Sonovein is sufficient to assure conformity of the Sonovein 2 with the respected essential requirements. At the same time, the compagny wishes to pursue the standardisation of the clinical practice with the second generation device and is, therefore, conducting this limited trial in 20 evaluable cases (from the planned 22 patients to be included). A "case" is defined as procedure conducted on a distinct vein.

NCT ID: NCT04249661 Completed - Venous Leg Ulcer Clinical Trials

Differential Effects of Bacteria Colonising Venous Leg Ulcers on Pain and Healing Rates

Start date: January 9, 2020
Phase:
Study type: Observational

This Study aims to identify whether venous leg ulcers which are colonised by Pseudomonas Aeruginosa cause more pain than those which are not and if this bacteria affects healing time. This may determine how venous ulcer infections are treated in order to improve symtomatology and quality of life for patients with these chronic wounds.

NCT ID: NCT04046120 Completed - Venous Ulcer Clinical Trials

Comparison of the Effectiveness of Two Medical Compression Bandage Application Techniques by Measuring Interface Pressures Depending on Whether or Not the Heel is Included in Patients With Open Venous Ulcers

COMPARACHILLE
Start date: October 11, 2019
Phase: N/A
Study type: Interventional

The importance of wearing medical compression to heal the venous ulcer has already been shown. However, no studies have been carried out on variations in medical compression tape and their impact on interface pressures which explains the lack of consensus on how to lay, including or not to include the heel. Studies on adherence to patients with medical compression have been carried out showing that one of the determining factors is comfort. The investigators therefore wish to conduct a randomized open prospective quantitative study comparing these two modes: including or not the heel .