Venous Insufficiency Clinical Trial
Official title:
IN-BALANCE VLU Inflammation, Bacteria, & Angiogenesis Effects in Launching Venous Leg Ulcer Healing
This trial is a prospective, randomized, controlled, multi-center study of subjects presenting with chronic lower extremity venous ulcers. The study will evaluate the safety and effectiveness of MIST Therapy® plus standard of care (MIST+SOC) compared to Standard of Care (SOC) alone in the treatment of lower extremity venous ulcers.
The study compared the treatment effect of non-contact low frequency ultrasound in addition to standard of care versus standard of care alone in healing chronic venous leg ulcers in subjects who had documented venous stasis and reflux. Subjects that were screened and met the major inclusion criteria received standardized treatment of 30 to 40 mmHg compression, moist wound healing dressings, and debridement for a two week run-in period. If their study ulcer did not decreased by greater than 30% they were eligible for randomization. The primary endpoint was wound area reduction after four (4) weeks of study treatment. The study was performed at 22 study centers. The study included two sub-studies: fluid and tissue analysis and a wound recidivism registry that are ongoing. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05507346 -
A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema
|
N/A | |
Completed |
NCT04469361 -
The Effect of Training on Hemodynamic Factors in Ballet Dancer
|
||
Recruiting |
NCT05633277 -
Outcomes of Sclerotherapy of the Ulcer Bed Compared to a Combination of Ablation and Injections
|
N/A | |
Completed |
NCT03283800 -
Copper Impact on Venous Insufficiency and Lipodermatosclerosis
|
N/A | |
Terminated |
NCT03311269 -
A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency
|
Phase 2 | |
Withdrawn |
NCT01680809 -
Compliance of Compression Therapy in Healed Venous Ulcerations
|
N/A | |
Completed |
NCT00617825 -
Feasibility Study of Cryotherapy for Chronic Venous Disorders
|
N/A | |
Active, not recruiting |
NCT00270972 -
The Evaluation of OrCel for the Treatment of Venous Ulcers
|
N/A | |
Completed |
NCT01701661 -
Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux
|
N/A | |
Active, not recruiting |
NCT06369207 -
Investigation of the Transmission Pathways of Reflux in Patients With Chronic Venous Insufficiency
|
||
Completed |
NCT04461132 -
The Effect of Manual Lymphatic Drainage
|
N/A | |
Recruiting |
NCT04546750 -
Prospective Cohort Study for Varicose Veins Incidence and Natural Course
|
||
Not yet recruiting |
NCT03543007 -
Evaluating the Safety and Efficacy of GrafixPLâ„¢PRIME for the Treatment of Chronic Venous Leg Ulcers
|
N/A | |
Active, not recruiting |
NCT02397226 -
Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery
|
N/A | |
Not yet recruiting |
NCT01110512 -
Comparative Efficacy of Two Preparations of the Association Diosmin (450 mg) + Hesperidin (50 mg) in the Treatment of Chronic Venous Insufficiency (CVI)
|
Phase 3 | |
Completed |
NCT00565604 -
Safety and Efficacy of Endovenous Laser Ablation for the Resolution of Incompetent Perforator Veins
|
N/A | |
Completed |
NCT01298908 -
Comparison of Treatments in Venous Insufficiency
|
N/A | |
Active, not recruiting |
NCT00841178 -
Endovenous Laser Therapy (EVLT) for Sapheno-Popliteal Incompetence and Short Saphenous Vein (SSV) Reflux: A RCT
|
N/A | |
Not yet recruiting |
NCT03652025 -
The Effectiveness of Trans-catheter Foam Sclerotherapy of Pelvic and Atypical Lower Limb Varicosities
|
N/A | |
Completed |
NCT03755180 -
Exercise Training in Venous Insufficiency
|
N/A |