Clinical trials: Leg Ulcers Venous
Chronic Venous Hypertension With Ulcer
Standard Compression Therapy With/Without Application of Skin Allograft (Theraskin) for Venous Leg Ulcer Treatment
This study will compare the efficacy of using standard compression therapy for treatment of chronic venous leg ulcers vs. the standard compression therapy with the additional use of the application of a human allograft (Theraskin)
- Trial name
- NCT03935386
- Testing
- Standard Multi-layered Compression dressing, Standard Multi-layered Compression dressing with a cryopreserved skin allograft (TheraSkin)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Solsys Medical LLC
Pathologic Processes, Diabetes Mellitus
Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs
The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers…
- Conditions
- Pathologic Processes, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases
- Trial name
- C5CAMP (NCT06674980)
- Testing
- Standard of Care - DFU, AM/Single - DFU, AM/Double - DFU
- Where
- United States
- Volunteers
- 177 people
- Sponsor
- C5 Biomedical
Diabetic Foot Ulcer, Venous Leg Ulcer
DETEC® Esterase for Screening Wound Infection at Point of Care
This non-interventional, single-blinded, prospective, observational study assesses the planar distribution of leukocyte esterase in wounds by placing wound exudates soaked wound dressings in the DETEC® Esterase device during…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- Trial name
- NCT04614870
- Testing
- DETEC® Esterase
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Progenitec Inc.
Partial Thickness Wound, Pressure Ulcer
The RESPOND Registry
The RESPOND Registry is an observational study to assess the impact of PuraPly™ AM on the management of wounds in real world clinical settings; no experimental intervention is involved.
- Conditions
- Partial Thickness Wound, Pressure Ulcer, Venous Ulcer, Diabetic Ulcer
- Trial name
- RESPOND (NCT03286452)
- Testing
- PuraPly™ Antimicrobial Wound Matrix
- Where
- 15 sites in United States
- Volunteers
- 310 people
- Sponsor
- Organogenesis
Venous Ulcer, Venous Stasis Ulcer
Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers
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.
- Conditions
- Venous Ulcer, Venous Stasis Ulcer, Ulcer
- Trial name
- NCT01853384
- Testing
- HP802-247, HP802-247 Vehicle
- Where
- 46 sites in Belgium, Czechia and 3 more
- Volunteers
- 252 people
- Sponsor
- Healthpoint
Varicose Ulcer, Veins Diseases
Treatment of Insufficient Superficial and Perforating Veins of the Lower Limb Using HIFU
This is a single-center prospective study with a planned accrual of 35 patients with diagnosed symptomatic Lower Limb Veins System (Superficial, Perforating) Insufficiency (including recurrence at the thigh/groin level after…
- Conditions
- Varicose Ulcer, Veins Diseases, Vein, Varicose
- Trial name
- Archimedes01 (NCT03304834)
- Testing
- ECHOPULSE
- Where
- Austria
- Volunteers
- 50 people
- Sponsor
- Theraclion
Hard to Heal Wounds, Venous Leg Ulcers
Efficacy and Safety Study of EscharEx to Treat (Debride) Hard to Heal Wounds
The main objective of this study is to assess the safety and the efficacy of EscharEx in preparing the wound's bed in patients with hard to heal venous leg ulcers, diabetic lower extremity ulcers and traumatic/post operative…
- Conditions
- Hard to Heal Wounds, Venous Leg Ulcers, Diabetic Lower Extremity Ulcers, Traumatic/ Post Operative Wounds
- Trial name
- NCT02020746
- Testing
- EscharEx, Gel Vehicle
- Where
- 8 sites in Israel
- Volunteers
- 111 people
- Sponsor
- MediWound Ltd
Venous Leg Ulcer
Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
This observations safety study is intended for subject who participated in the 802-247-09-029 study with the investigational product HP802-247 for venous leg ulcers and received at least one application of HP802-247 or Vehicle…
- Trial name
- NCT01658618
- Testing
- HP802-247
- Where
- 49 sites in United States, Canada
- Volunteers
- 440 people
- Sponsor
- Healthpoint
Acute and Chronic Wounds, Pressure Ulcers
Clinical Evaluation of the SNaP Wound Care System
The purpose of this study is to assess the efficacy of design improvements of the Spiracur SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current and new design iterations of components of…
- Conditions
- Acute and Chronic Wounds, Pressure Ulcers, Trauma Wounds, Diabetic Foot Ulcers
- Trial name
- NCT01113658
- Testing
- SNaP Wound Care System
- Where
- 2 sites in United States
- Sponsor
- 3M
Ulcer, Leg Ulcer
Study of VF001-DP in Patients With Chronic Venous Leg Ulcers
The purpose of this study is to determine if VF001-DP improves wound healing in chronic venous leg ulcers compared to standard care only.
- Conditions
- Ulcer, Leg Ulcer, Varicose Ulcer, Pathologic Processes
- Trial name
- NCT02973893
- Testing
- VF001-DP LD, VF001-DP HD
- Where
- 17 sites in United States
- Volunteers
- 156 people
- Sponsor
- Factor Therapeutics Ltd.
Wound Heal, Venous Leg Ulcer
INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone
INNOVEN is a multi-center randomized controlled clinical trial to evaluate the efficacy of porcine placental extracellular matrix (PPECM) and standard of care (SOC) versus SOC alone in the closure of non-healing venous leg ulcers…
- Trial name
- NCT06606210
- Testing
- InnovaMatrix® AC
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- ConvaTec Inc.
Pressure Ulcer, Diabetic Foot Ulcer
An Open, Non-comparative, Multicenter Investigation to Evaluate the Safety and Performance of Exufiber Ag+, a Gelling Fiber Silver Dressing, When Used in Medium to High Exuding Chronic Wounds
An open, non-comparative, multicenter investigation to evaluate the safety and performance of Exufiber Ag+, a gelling fiber silver dressing, when used in medium to high exuding chronic wounds
- Conditions
- Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer
- Trial name
- NCT05494450
- Testing
- ExufiberAG+
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- Molnlycke Health Care AB
Lower Extremity Chronic Venous Ulcers
Assessment of the Safety and Efficacy of DERMASTREAM™ - ENZYSTREAM™ System for the Treatment of Chronic Venous Ulcers
The study objectives are to evaluate DermastreamTM - EnzystreamTM system safety, tolerability and efficacy, as a potent method for debridement of nonhealing lower extremity chronic venous ulcers patients.
- Trial name
- ENZ-DER-002-IL (NCT00485329)
- Testing
- Papain
- Where
- 3 sites in Israel
- Volunteers
- 48 people
- Sponsor
- EnzySurge
Venous Leg Ulcer, Diabetic Foot Ulcer
A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers
This study will be a multicenter, prospective, open label, one-arm study intended to assess the clinical performance and safety of EX-02 in debridement of lower leg ulcers: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcer (DFU).
- Trial name
- NCT04817228
- Testing
- EscharEx (EX-02 formulation)
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- MediWound Ltd
Diabetic Foot Ulcer
DermACELL in Subjects With Chronic Wounds of the Lower Extremities
The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).
- Trial name
- NCT01970163
- Testing
- DermACELL, GraftJacket, Conventional Care Dressings
- Where
- 12 sites in United States
- Volunteers
- 202 people
- Sponsor
- LifeNet Health
Determine Effectiveness of Theraskin in the Treatment of DFU and VLU
Clinical Trial to Examine Effectiveness of a Human Allograft for Treatment of DFU and VLU
Retrospective clinical study of 188 patients to examine effectiveness of human cryopreserved allograft in the treatment of diabetic foot ulcers and venous leg ulcers
- Trial name
- NCT03999281
- Testing
- Human Allograft (Theraskin)
- Where
- United States
- Volunteers
- 188 people
- Sponsor
- Solsys Medical LLC
Non-infected Venous Leg Ulcer, Venous Leg Ulcer
Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC
This study examines a patient population with a non-healing, non-infected venous leg ulcer (VLU) having adequate arterial perfusion with confirmed venous reflux.
- Conditions
- Non-infected Venous Leg Ulcer, Venous Leg Ulcer, Venous Insufficiency, Venous Stasis
- Trial name
- NCT06811909
- Testing
- BR-AC, Standard Care
- Where
- 22 sites in United States
- Volunteers
- 71 people
- Sponsor
- BioStem Technologies
Venous Leg Ulcers (VLUs)
Assessing Connected-Health, Pressure-Monitoring Technology for Improving Compression Therapy in Venous Leg Ulcer Treatment
This study evaluates the effectiveness of a connected-health, pressure monitoring technology (Tight Alright) to improve clinical outcomes of compression therapy in patients with venous leg ulcers (VLUs).
- Trial name
- ACHIEVE (NCT07152717)
- Testing
- A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Feeltect Limited
Venous Leg Ulcer
Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
Observe the long-term (1-year) outcomes of Dermagraft, compared with conventional treatment of four-layer compression bandaging therapy alone, in subjects who completed the ABH-Dermagraft-001-08 study.
- Trial name
- LTFU (NCT01891760)
- Testing
- Dermagraft, Profore
- Where
- 28 sites in United States, Estonia and 4 more
- Volunteers
- 225 people
- Sponsor
- Shire Regenerative Medicine, Inc.
Venous Leg Ulcer
Human Amniotic Membrane Grafting and Standard of Care Versus Standard of Care Alone in the Treatment of Venous Leg Ulcers
The purpose of this study is to determine whether the EpiFix human amniotic membrane is effective in the treatment of venous leg ulcers.
- Trial name
- NCT01552447
- Testing
- EpiFix, Compression Therapy
- Where
- 5 sites in United States
- Volunteers
- 98 people
- Sponsor
- MiMedx Group, Inc.