Clinical trials: Venous Stasis Ulcer
Chronic Wound, Venous Leg Ulcer
Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.
- Conditions
- Chronic Wound, Venous Leg Ulcer, Diabetic Foot Ulcer
- Trial name
- NCT03662997
- Testing
- Bordered Five-Layer Foam Dressing, Hydropolymer Foam Dressing, Hydrocellular Multi-Layer Foam Dressing
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Molnlycke Health Care AB
Venous Leg Ulcers
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2
This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S.
- Trial name
- NCT01737762
- Testing
- HP802-247, Vehicle
- Where
- 43 sites in United States, Canada and 1 more
- Volunteers
- 155 people
- Sponsor
- Healthpoint
Venous Leg Ulcer
Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
This study randomly assigns patients with venous leg ulcers to receive standard therapy (compression) alone or compression plus Dermagraft(R).
- Trial name
- DEVO (NCT00909870)
- Testing
- Dermagraft(R), Profore
- Where
- 70 sites in United States, Austria and 6 more
- Volunteers
- 537 people
- Sponsor
- Organogenesis
Venous Ulcer of Leg
Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU)
This clinical study is a global, prospective, multi-center, randomized controlled trial to determine if the use of intravascular ultrasound (IVUS) as an adjunctive imaging modality and as an interventional treatment guide will…
- Trial name
- IGuideU (NCT04696354)
- Testing
- IVUS, Continued Compression Therapy/Stockings
- Where
- 17 sites in United States, Australia and 3 more
- Volunteers
- 12 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Venous Leg Ulcer, Chronic Venous Insufficiency
Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)
The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after 4 weeks of treatment using a dual action pneumatic compression device.
- Conditions
- Venous Leg Ulcer, Chronic Venous Insufficiency, Venous Stasis Ulcer, Venous Ulcer
- Trial name
- NCT02395302
- Testing
- Dual Action Pneumatic Compression
- Where
- 6 sites in United States
- Volunteers
- 28 people
- Sponsor
- Tactile Medical
Venous Hypertension Ulcers, Venous Stasis Ulcer
Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence
The goal of this study is to test MUSTCOOL, a home-based self-monitoring and self-management ulcer prevention intervention for patients with newly healed chronic venous leg and diabetic foot ulcers.
- Conditions
- Venous Hypertension Ulcers, Venous Stasis Ulcer, Venous Ulcer, Venous Insufficiency
- Trial name
- MUSTCOOL (NCT02626156)
- Testing
- Cooling gel pack, Cooling cotton pack
- Where
- 2 sites in United States
- Volunteers
- 140 people
- Sponsor
- Medical University of South Carolina
Leg Ulcer, Varicose Ulcer
Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers
This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg ulcers and to give preliminary information about the efficacy of two different Celaderm(TM) dosing regimens.
- Trial name
- NCT00399308
- Testing
- Celaderm (Frozen Cultured Epidermal Allograft), Control (compression bandaging)
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- Shire
Varicose Ulcer
MIST Ultrasound Therapy Compared to United Kingdom Standard Care for the Treatment of Non-healing Venous Leg Ulcers
Chronic venous leg ulcers (VLUs) impact negatively on patients' quality of life. Standard treatment in the UK for patients with VLUs is compression bandaging or stockings.
- Trial name
- NCT01671748
- Testing
- MIST ultrasound therapy, Standard Care
- Where
- United Kingdom
- Volunteers
- 47 people
- Sponsor
- Cardiff and Vale University Health Board
Venous Leg Ulcer
VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging
The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area reduction at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.
- Trial name
- NCT02680834
- Testing
- Dual Action Pneumatic Compression Device, Multi-Layer Bandaging
- Where
- 18 sites in United States
- Volunteers
- 56 people
- Sponsor
- Tactile Medical
Burns, Trauma
Split Thickness Donor Site Healing With MIST Study
Subjects requiring skin grafting due to burns, trauma, or chronic venous ulcers with split thickness donor sites expected to be between 20 and 200 square cm will be consecutively screened for study eligibility.
- Conditions
- Burns, Trauma, Venous Ulcers
- Trial name
- NCT01214980
- Testing
- MIST Therapy, Standard of care
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Celleration, Inc.
Venous Leg Ulcer
VLU Dressing Study
The goal of the study is to investigate the effectiveness of Cutimed Sorbact (Study Device) in modifying bacterial load in venous leg ulcers (VLU).
- Trial name
- NCT03621592
- Testing
- Cutimed® Sorbact®, Acticoat®
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Miami
Venous Ulcer
Flexitouch Treatment for Venous Ulcers
This is a study to compare the healing process of venous stasis ulcers when the Flexitouch® system is added to the standard treatment of venous ulcers.
- Trial name
- NCT00847002
- Testing
- Standard Wound Care, Flexitouch System with Standard Wound Care
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Tactile Systems Technology, Inc.
Venous Stasis Ulcers
Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers
The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers
- Trial name
- SSVS (NCT00832091)
- Testing
- Thymosin Beta 4
- Where
- 8 sites in Italy, Poland
- Volunteers
- 72 people
- Sponsor
- RegeneRx Biopharmaceuticals, Inc.
Stasis Dermatitis
Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis
This is a Phase 2a, randomized, double blind, vehicle controlled, parallel group, proof of concept study that will include participants with stasis dermatitis without active skin ulceration, who will receive crisaborole ointment…
- Trial name
- NCT04091087
- Testing
- crisaborole ointment, vehicle ointment
- Where
- 4 sites in United States
- Volunteers
- 66 people
- Sponsor
- Pfizer
Diabetic Foot Ulcer, Venous Leg Ulcer
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care.
- Trial name
- NCT04927702
- Testing
- Synthetic Hybrid-Scale Fiber Matrix, Standard of Care, Living Cellular Skin Substitute
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Acera Surgical, Inc.
Leg Ulcers Venous, Dehiscence, Surgical Wound
Blu Light for Ulcers Reduction
Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks.
- Trial name
- BLUR (NCT04018924)
- Testing
- Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)
- Where
- 7 sites in Italy
- Volunteers
- 90 people
- Sponsor
- Emoled
Varicose Ulcer
Predictive of Biomarkers of Healing in Chronic Venous Ulceration of the Lower Limb
Chronic venous ulceration of the lower limb poses a significant problem to patients and healthcare providers alike. 1% of the population of Western countries have either an open or healed chronic venous ulcer.
- Trial name
- MOJITO (NCT01998932)
- Where
- 2 sites in United Kingdom
- Volunteers
- 28 people
- Sponsor
- Imperial College London
Venous Leg Ulcer
Trial on the Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel
The primary objective of the study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the treatment of hard-to heal venous leg ulcers compared to control saline irrigation solution and…
- Trial name
- NCT01153633
- Testing
- Prontosan Wound Irrigation Solution and Prontosan Wound Gel
- Where
- United Kingdom
- Volunteers
- 34 people
- Sponsor
- B. Braun Ltd. Centre of Excellence Infection Control
Venous Disease
Perforator Vein Injection for Symptomatic Venous Disease
The primary objective of this study is to compare two treatment strategies for symptomatic venous stasis disease with and without venous ulcer. These treatments are compression therapy alone vs.
- Trial name
- Dillavou (NCT03363633)
- Testing
- sodium tetradecyl sulfate, Compression
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Ellen Dillavou
Venous Leg Ulcer
Evaluation of Pain Associated With the Removal of Wound Dressing During Care of Venous Leg Ulcer. Comparison of the Efficacy and Safety of Two Dressings Urgotul and TulleGras
Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with removal of wound dressing during care of venous leg ulcer
- Trial name
- NCT02104180
- Testing
- Urgotul, TulleGras M.S.
- Where
- 27 sites in France
- Volunteers
- 62 people
- Sponsor
- Mylan Inc.