Clinical trials: Vein Injury
Pressure Ulcers, Venous Ulcers
Prospective PuraPly™ AM Case Series Study
The PuraPly AM case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylene biguanide hydrochloride (PHMB) and is intended for the…
- Conditions
- Pressure Ulcers, Venous Ulcers, Diabetic Ulcers, Surgical Wounds
- Trial name
- NCT03070925
- Testing
- PuraPly™ Antimicrobial Wound Matrix
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Organogenesis
Diabetic Foot Ulcer, Venous Leg Ulcer
Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center
Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT) to assess rate and frequency of wound healing and associated financial savings, when using Medaxis debritom+ versus standard of care as…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Surgical Wound Dehiscence, Traumatic Wounds
- Trial name
- EVIDENT (NCT04920253)
- Testing
- Study Device Debridement, SOC Debridement
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Medaxis, LLC
Wounds and Injuries
Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds
The objective of this study is to evaluate the performance of Polyheal-1 compared to Saline in the treatment of recalcitrant wounds including venous, post-operative and post-traumatic chronic wounds with different etiologies…
- Trial name
- NCT00552643
- Testing
- Suspension of polystyrene beads (POLYHEAL 1), Saline (0.9% NaCl)
- Where
- 6 sites in Israel
- Volunteers
- 60 people
- Sponsor
- Polyheal Ltd.
Venous Ulcer, Pressure Ulcer
Safety and Efficacy of the Fruit-based Product OPAL A for the Treatment of Chronic Venous and Pressure Ulcers
The purpose of this study is to examine the safety and efficacy of the fruit-based product OPAL A for the treatment of chronic venous and pressure ulcers.
- Trial name
- NCT00933348
- Testing
- OPAL A
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- Phoenix Eagle Company
Venous Leg Ulcer, Leg Ulcers Venous
Efficacy Study for Geko Device in VLU Patients
Eight weeks, comprised of four weeks Run-in Phase of Standard Care (SC) treatment followed by four weeks of treatment allocated by randomisation (Treatment Phase).
- Conditions
- Venous Leg Ulcer, Leg Ulcers Venous, Leg Ulcer, Wound Leg
- Trial name
- NCT03396731
- Testing
- geko™ medical device
- Where
- 23 sites in United Kingdom
- Volunteers
- 171 people
- Sponsor
- Firstkind Ltd
Wound Infection, Wound Heal
Analytical Performance of pH, HNE and MPO Levels in Detecting Wound Infection Proof of Concept Biomarker Study
The purpose of this study is to evaluate the effectiveness of a novel combination of biomarkers, pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a…
- Trial name
- INDICATE (NCT04979637)
- Sponsor
- ConvaTec Inc.
Burn, Trauma
Trial of Zesteem (Estradiol) in Healing of Split Thickness Skin Graft Donor Sites
This trial will assess the effects of Zesteem (estradiol) on the healing of split thickness skin graft donor sites in patients aged 18-85 years.
- Conditions
- Burn, Trauma, Varicose Ulcer
- Trial name
- NCT00426972
- Testing
- estradiol (Zesteem)
- Where
- 30 sites in Germany, Latvia and 2 more
- Volunteers
- 148 people
- Sponsor
- Renovo
Wound, Venous Leg Ulcer
Geko™ Cross Therapy Registry - Wound
The geko™ Cross Therapy REGISTRY - Wound is a prospective, observational, anonymised data collection Registry with no experimental treatment that will fulfil an unmet need for an observational Registry to provide long-term…
- Conditions
- Wound, Venous Leg Ulcer, Diabetic Foot Ulcer, Arterial Leg Ulcer
- Trial name
- CTR-Wound (NCT05007301)
- Testing
- geko device
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 2,500 people
- Sponsor
- Firstkind Ltd
Pressure Ulcer, Arterial Ulcers
Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Suprasorb® A + Ag wound dressing and rope, to collect safety data regarding expected adverse events and to detect potential unexpected…
- Conditions
- Pressure Ulcer, Arterial Ulcers, Venous Leg Ulcer, Diabetic Ulcers
- Trial name
- NCT05646121
- Testing
- Suprasorb® A + Ag wound dressing and rope
- Where
- 8 sites in Poland
- Volunteers
- 99 people
- Sponsor
- Lohmann & Rauscher
Wound, Nonpenetrating
Healing Chronic Venous Stasis Wounds With Autologous Cell Therapy
This is a prospective, randomized, single-site, safety and efficacy study of subjects with chronic venous stasis ulcers. Patients will fall into two categories: treatment arm (24 subjects) and non-treatment or control arm (12…
- Trial name
- NCT02961699
- Testing
- Transpose ® RT System, debridement/dressing of wound
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- InGeneron, Inc.
Surgical Wound
AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites and providing reduced times to ambulation (TTA)…
- Trial name
- NCT03193021
- Testing
- Cardiva Mid-Bore VVCS, Manual compression
- Where
- 13 sites in United States
- Volunteers
- 204 people
- Sponsor
- Cardiva Medical, Inc.
Skin Ulcer Venous Stasis Chronic
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of CVU (Phase IIb)
The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction of CVUs) and safety (by monitoring adverse events [AEs]) of three dose groups of the investigational medicinal product (IMP)…
- Trial name
- NCT04971161
- Testing
- allo-APZ2-CVU
- Where
- 38 sites in Germany
- Volunteers
- 159 people
- Sponsor
- RHEACELL GmbH & Co. KG
Venous Leg Ulcer (VLU)
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
The main objective of this study is: To assess the efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo control,in debridement and wound bed preparation of Venous Leg Ulcers (VLU).
- Trial name
- VALUE (NCT06568627)
- Testing
- EscharEx (EX-03)
- Where
- 60 sites in United States, Austria and 7 more
- Volunteers
- 216 people
- Sponsor
- MediWound Ltd
Leg Ulcers, Leg Ulcers Venous
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Chronic lower limb ulcers, particularly those of venous etiology, are difficult-to-heal wounds that severely affect patients' quality of life. Adequate tissue oxygenation is essential for wound healing.
- Trial name
- NCT07901517
- Testing
- Vacuum Compression Therapy (VCT), Standard Wound Care
- Where
- Czechia
- Volunteers
- 20 people
- Sponsor
- BTL Industries Ltd.
Skin Lesion, Traumatic Ulcer
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
The aim of this clinical investigation is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three wound area measurement methods: Ruler using the Kundin method…
- Conditions
- Skin Lesion, Traumatic Ulcer, Hematoma, Pressure Ulcer
- Trial name
- NCT05729334
- Testing
- Clinicgram Euclides
- Where
- Spain
- Volunteers
- 65 people
- Sponsor
- Skilled Skin S.L.
Venous Leg Ulcers
Effectiveness of Aurix Therapy in Venous Leg Ulcers
The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which venous leg ulcers (VLU)n will be treated using Aurix and compared to patients receiving…
- Trial name
- NCT02940587
- Testing
- Aurix
- Where
- United States
- Sponsor
- Cytomedix
Ulcers
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Venous Leg Ulcers
This is a Phase II, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of MEBO in the treatment of 14 subjects with VLUs.
- Trial name
- NCT01138436
- Testing
- MEBO Wound Ointment (MEBO), Standard of Care
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Skingenix, Inc.
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 Thromboembolism
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery
The primary objective was to compare the efficacy of once daily [q.d] subcutaneous [s.c.] injections of Semuloparin sodium (AVE5026) with q.d. s.c.
- Trial name
- SAVE-HIP2 (NCT00721760)
- Testing
- Enoxaparin sodium, Semuloparin sodium
- Where
- 25 sites in United States, Argentina and 23 more
- Volunteers
- 1,003 people
- Sponsor
- Sanofi
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.