Venous Ulcers Clinical Trial
Official title:
Effect of Compressive Therapies on the Healing of Venous Ulcers in Primary Health Services: Randomized Clinical Trial
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.
The primary objective is to compare the effect of two compressive therapies, high compression elastic bandage and Unna boot, on time and on the healing characteristics of venous ulcers in Primary Health Care and the secondary objectives are to verify the effects of the therapies in tissue integrity and at the level of pain, to identify quality of life of the participants and to evaluate the cost-effectiveness of the two therapies from the perspective of the Unified Health System. A randomized clinical trial is being carried out in two Primary Health Services in Porto Alegre city, with people with active venous ulcer. 126 venous ulcers, 63 in each group will be followed. The A group receives elastic compressive therapy (high compression elastic bandage) and the B group receives inelastic compressive therapy (Unna boot) by randomization. Once a week, during 26 weeks, a nurse applies the therapy according to the randomization group. And a blind evaluator for therapies will assess the characteristics of the ulcers and the size, on the first day and in every two weeks until 26ª week. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00207818 -
Treatment of Cutaneous Ulcers With a Novel Biological Dressing
|
Phase 1/Phase 2 | |
Terminated |
NCT00545298 -
Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers
|
Phase 2 | |
Completed |
NCT03070925 -
Prospective PuraPly™ AM Case Series Study
|
N/A | |
Not yet recruiting |
NCT01491438 -
Plasma Rich Growth Factors in Venous Ulcers
|
N/A | |
Completed |
NCT01348581 -
Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing
|
N/A | |
Completed |
NCT02034396 -
Clinical Implications of Genetic Variations of Venous Stasis Ulceration
|
N/A | |
Completed |
NCT06280053 -
HealiAid in the Treatment of Different Wounds
|
N/A | |
Completed |
NCT02364921 -
Effectiveness of Double-layer Compression Therapy in the Healing of Chronic Venous Ulcers in Primary Health Care
|
N/A | |
Suspended |
NCT02930499 -
Effect of Hyaluronic Acid ECM on Venous Ulcers
|
N/A | |
Recruiting |
NCT06350695 -
The ROle of Compression StocKings in Heart Failure Patients
|
N/A | |
Completed |
NCT01214980 -
Split Thickness Donor Site Healing With MIST Study
|
N/A | |
Terminated |
NCT00613808 -
Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers
|
Phase 2 | |
Completed |
NCT01509599 -
Cooling Lower Leg Skin to Prevent Venous Leg Ulcers in Patients With Poor Vein Circulation
|
Phase 1/Phase 2 | |
Completed |
NCT02632695 -
Physical Activity Interventions for Leg Ulcer Patients
|
N/A | |
Terminated |
NCT02071979 -
Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds
|
N/A |