Clinical trials: Stasis Ulcer
Lymphedema
Effect of Intermittent Pneumatic Compression on Ulcer Healing in Subjects With Secondary Lymphedema
This is a randomized, controlled, parallel group, open label, clinical trial to evaluate the effectiveness of intermittent, gradient, pneumatic compression (IPC)on the healing of venous ulcers in subjects diagnosed with chronic…
- Trial name
- NCT01079299
- Testing
- Intermittent, gradient, pneumatic compression device
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Calvary Hospital, Bronx, NY
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
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
Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately or Strongly Exuding Venous and Mixed Ulcers of Predominantly Venous Origin
The investigation is designed as an open, randomized, non-inferiority, multi-centre investigation. 212 evaluable subjects will be randomised.
- Trial name
- PD-497314 (NCT02921750)
- Testing
- Exufiber Gelling Fibre Dressing, Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre
- Where
- 33 sites in Czechia, Denmark and 4 more
- Volunteers
- 248 people
- Sponsor
- Molnlycke Health Care AB
Varicose Ulcer, Venous Insufficiency
Amniotic Membrane Allograft Application in the Management of Venous Leg Ulcerations
The purpose of this study is to evaluate and compare healing characteristics, reduction in the size of the wound and to measure complete healing of the wound following the application of a biologic product dressing instead of the…
- Trial name
- AmnioExCel (NCT02929056)
- Testing
- AmnioExCel dressing and compression therapy, SOC alginate dressing and compression therapy
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Prisma Health-Upstate
Venous Leg Ulcer, Venous Stasis Ulcers
Dose Finding Study of HP802-247 in Venous Leg Ulcers
This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of HP802-247, together…
- Trial name
- NCT00852995
- Testing
- HP802-247
- Where
- 30 sites in United States, Canada
- Volunteers
- 228 people
- Sponsor
- Healthpoint
Wounds
Positive Predictive Value of the MolecuLight i:X Imaging Device to Predict the Presence of Bacteria in Chronic Wounds
This is a non-randomized evaluation for which 50 patients will be imaged at the Southwest Regional Wound Care Center, Lubbock, Texas, who present with a chronic wound and are receiving standard treatment.
- Trial name
- NCT02682069
- Testing
- MolecuLight i:X Imaging Device
- Volunteers
- 30 people
- Sponsor
- MolecuLight Inc.
Venous Stasis Ulcer
Flexitouch Compression System for Venous Stasis Ulcer
The researchers hypothesize that utilization of the Flexitouch system will improve the healing rates of (venous stasis ulcers) VSU compared to traditional compression wrapping therapy alone.
- Trial name
- NCT00534937
- Testing
- Compression wrapping, Flexitouch compression pump
- Where
- 2 sites in United States
- Volunteers
- 89 people
- Sponsor
- West Penn Allegheny Health System
Diabetic Foot Ulcer, Pressure Ulcer
A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing Wounds in Elderly Population in Specialized Nursing Facilities Using RD1
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…
- Conditions
- Diabetic Foot Ulcer, Pressure Ulcer, Venous Leg Ulcer, Trauma Injury
- Trial name
- NCT04577183
- Testing
- RD1 System
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- RedDress Ltd.
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
Lower Extremity Wound Infected, Venous Stasis Ulcers
V.A.C. VeraFlo™ Instillation Therapy vs V.A.C. Ulta™ Therapy on Biofilm in Chronically Infected Wounds
This study would like to determine if using negative pressure wound therapy with an instillation of .125% Dakins is more effective than using negative pressure wound therapy alone on biofilm removal, disruption and elimination in…
- Trial name
- NCT02009501
- Testing
- VAC VeraFlo with Dakins Instillation, VAC Ulta Therapy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- St. Luke's-Roosevelt Hospital Center
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 Leg Ulcer
Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers
The goal of this project is to use genomic profiling, candidate genes and proteins to develop guided surgical debridement to improve healing in chronic non-healing venous leg ulcers (VLUs) and to test the efficacy of this…
- Trial name
- NCT03796793
- Testing
- Wound Edge Debridement, Standard of Care Treatment
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- University of Miami
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.
Venous Leg Ulcer, Venous Stasis Ulcer
Safety Follow-Up to HP 802-247-09-015
This is a 24-week observational follow safety study for Study 802-247-09-015.
- Trial name
- NCT00900029
- Testing
- No HP802 Treatment, No HP802 Vehicle Treatment
- Where
- 30 sites in United States, Canada
- Volunteers
- 206 people
- Sponsor
- Healthpoint
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
Venous Stasis Ulcer
Efficacy Study of the Application of Low Level Laser Light to Treat Venous Stasis Ulcers
The purpose of this study is to determine whether low level laser light therapy is effective as an adjunctive therapy to the healing of venous stasis leg ulcers.
- Trial name
- NCT01376050
- Testing
- Erchonia ML Scanner (MLS)
- Where
- 2 sites in United States, France
- Volunteers
- 24 people
- Sponsor
- Erchonia Corporation
Surgical Incision, Ulcer Foot
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot…
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg
- Trial name
- PICO14 (NCT05234632)
- Testing
- PICO 14 single-use Negative Pressure Wound Therapy System
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Smith & Nephew, Inc.
Venous Leg Ulcer (VLU)
A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers
This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system.
- Trial name
- NCT02167815
- Testing
- Mepilex XT, standard care
- Where
- 3 sites in Czechia
- Volunteers
- 30 people
- Sponsor
- Molnlycke Health Care AB
Venous Leg Ulcer, Diabetic Foot
AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period
Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing
- Trial name
- NCT05892341
- Testing
- AQUACEL® Ag+ Extra™, Cutimed® Sorbact®
- Where
- 18 sites in Colombia, Germany and 1 more
- Volunteers
- 203 people
- Sponsor
- ConvaTec Inc.