Clinical trials: Leg Ulcers, open to volunteers
Venous Leg Ulcers, Venous Leg Ulcers (VLUs)
Modified Platform Trial Assessing Multiple Umbilical Cord-based CAMPs and SOC v SOC Alone in the Treatment of Hard-to-Heal VLUs
The purpose of this study is to evaluate the efficacy of two dehydrated human umbilical cord-based medical devices, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in…
- Conditions
- Venous Leg Ulcers, Venous Leg Ulcers (VLUs), Venous Leg, Leg Ulcers
- Trial name
- CORDSTIM-VLU (NCT07449988)
- Testing
- Standard of Care (SOC), Corplex P, Theracor
- Volunteers
- 272 people
- Sponsor
- StimLabs
Venous Ulcer
Monitoring of Venous Ulcers Using a Bioimpedance Measurement Based Method and System
The purpose of this study is to investigate the functionality of a new type of wound monitoring method and measurement system for monitoring healing of venous ulcers.
- Trial name
- WoundWatch® (NCT05805137)
- Testing
- WoundWatch® wound monitoring system
- Where
- 2 sites in Finland, Poland
- Volunteers
- 20 people
- Sponsor
- CutoSense Oy
Diabetic Foot, DFU
Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers.
- Conditions
- Diabetic Foot, DFU, Diabetic Foot Ulcer, Foot Ulcer, Diabetic
- Trial name
- BIOCAMP (NCT07089602)
- Testing
- Standard of Care DFU, Tri-Membrane Wrap™ DFU, Membrane Wrap™ DFU
- Where
- United States
- Volunteers
- 650 people
- Sponsor
- BioLab Holdings
Diabetes Mellitus, Type 2, Diabetic Foot
Non-invasive Imaging for In-vivo Quantification of Skin Composition and Structure
The goal of this clinical investigation is to explore a non-invasive technology for measuring the microcirculatory structure, composition and function in patients from a primary care population. The main aims are: 1.
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Foot, Peripheral Arterial Disease, Skin Cancer
- Trial name
- Spectrum1 (NCT06976073)
- Where
- 3 sites in Sweden
- Volunteers
- 8,000 people, healthy volunteers welcome
- Sponsor
- HJN Sverige AB/Neko Health
Diabetic Foot Ulcer, DFU
Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy
The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks…
- Conditions
- Diabetic Foot Ulcer, DFU, Diabetic Foot Ulcer (DFU), Foot Ulcer Due to Type 1 Diabetes Mellitus
- Trial name
- RENEW (NCT07086443)
- Testing
- Activate™ Matrix, AmnioDefend™ FT Matrix, Palisade™ DM Matrix
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- Sequence LifeScience, Inc.
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.
Venous Leg Ulcer
Evaluating the Efficacy of NeoThelium FT in the Treatment of Venous Leg Ulcers
This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers.
- Trial name
- NCT06930768
- Testing
- Standard of Care, NeoThelium FT
- Volunteers
- 132 people
- Sponsor
- NuScience Medical Biologics, LLC
Diabetic Foot Ulcers (DFUs)
Phase 2a Dose Finding Study of Nu-3 Gel in Subjects With Mild iDFU
The goal of this clinical trial is to learn if drug Nu-3 works to treat mildly infected diabetic foot ulcers in adults with Type 1 or Type 2 diabetes at 3 different dose levels. It will also learn about the safety of drug Nu-3.
- Trial name
- NCT07565506
- Testing
- Antimicrobial agent
- Where
- 6 sites in United States
- Volunteers
- 24 people
- Sponsor
- Lakewood-Amedex Inc
Venous Leg Ulcer (VLU)
Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers
The purpose of this study is to evaluate the efficacy, safety and economic benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of venous leg ulcers.
- Trial name
- VaLUe I (NCT06754735)
- Testing
- Topical Wound Oxygen Therapy
- Where
- United States
- Volunteers
- 212 people
- Sponsor
- AOTI Ltd.
Diabetic Foot Ulcer (DFU)
Evaluating the Efficacy of FoundationDRS Solo in Addition to Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers
The goal of this clinical trial is to learn if using FoundationDRS Solo improves healing of chronic, non-healing foot ulcers in diabetic patients.
- Trial name
- NCT07290673
- Testing
- FoundationDRS Solo, Standard of Care
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Samaritan Biologics
Chronic Ulcers
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
This prospective, randomized, single-blind, controlled clinical investigation evaluates the efficacy and safety of ZKARE®, a topical polymeric gel dressing, and its accessory applicator ZKAPI®, for the treatment of chronic…
- Trial name
- NCT07406152
- Testing
- ZKARE®, Standard Wound Care
- Where
- Spain
- Volunteers
- 134 people
- Sponsor
- i+Med S.Coop.
Diabetic Foot Ulcer
Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System in the Healing of Diabetic Foot Ulcers
This is a randomized controlled multi center study on diabetic patients with the aim of evaluating the efficacy of the adipose tissue processed with the SyntrFuge™ system in diabetic patients with diabetic foot ulcers.
- Trial name
- NCT05519501
- Testing
- Syntrfuge Microfragmented Fat, Standard of Care
- Volunteers
- 62 people
- Sponsor
- Syntr Health Technologies, Inc.
Leg Ulcer, Pressure Ulcer (PU)
Performance and Safety of Mepilex® Up in Leg and Foot Ulcers and Skin Tears
This post-market clinical follow-up investigation is designed to evaluate the performance and safety of Mepilex® Up when used for the management of exuding ulcers and skin tears on the leg and foot.
- Conditions
- Leg Ulcer, Pressure Ulcer (PU), Skin Tears, Foot Ulcer
- Trial name
- NCT07782008
- Testing
- Mepilex® Up
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcer
Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers
The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs).
- Trial name
- Mavericks (NCT05758545)
- Testing
- COMS One device
- Where
- 30 sites in United States
- Volunteers
- 450 people
- Sponsor
- Piomic Medical
Vascular Disease, Peripheral, Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics
The goal of this observational study is to learn if the measures of tissue oxygenation from the MIMOSA Pro imaging device correlate to standard vascular assessment tools in patients who receiving a lower extremity vascular…
- Trial name
- NCT06899113
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- MIMOSA Diagnostics Inc.
Diabetic Foot Disease, Diabetic Foot Infection
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
The goal of this clinical trial is to evaluate the performance of a self-monitoring system (Solsius SelfCare) to detect pre-ulcerative clinical abnormalities in adults living with type 1 or 2 diabetes at high podiatric risk…
- Conditions
- Diabetic Foot Disease, Diabetic Foot Infection, Diabetic Foot Infections, Diabete Type 1
- Trial name
- DIAFOOTEM (NCT07910721)
- Testing
- Solsius SelfCare
- Where
- 3 sites in France
- Volunteers
- 60 people
- Sponsor
- Solsius
Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft
a Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers
BIOxHEAL is an investigational placental-derived biologic being evaluated for the treatment of nonhealing diabetic foot ulcers. Adults with type 1 or type 2 diabetes who have a diabetic foot ulcer that has not healed with…
- Conditions
- Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft, Biologic
- Trial name
- AB BIOH - DFU (NCT07852338)
- Testing
- Standard of Care, BIOxHEAL (human amniotic membrane allograft)
- Where
- United States
- Volunteers
- 253 people
- Sponsor
- Applied Biologics, LLC
Chronic Ulcers, Diabetic Foot Ulcers (DFU)
Case Series of StimLabs Dehydrated Human Umbilical Cord Particulate for Acute and Chronic Wounds
The purpose of this observational case series is to assess the use of Corplex P as a resorbable particulate device used to cover, protect, and provide a moist wound environment when added to the standard of care treatment of…
- Conditions
- Chronic Ulcers, Diabetic Foot Ulcers (DFU), DFU, Ulcer
- Trial name
- NCT07414368
- Testing
- Corplex P is used to cover, protect, and provide a moist wound environment
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- StimLabs
Wounds and Injuries, Burns
Clinical Registry Collecting Real World Evidence on Wound Care Treatments
The proposed registry Sponsor (Siddhey LLC) will collect data on various wound treatments in real life settings. Data collection will facilitate the analysis of the safety and efficacy of wound treatments.
- Conditions
- Wounds and Injuries, Burns, Mohs Surgery, Diabetic Foot Ulcer Mixed
- Trial name
- SIDDX (NCT06328010)
- Testing
- Various types of wound care treatments
- Where
- 12 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- Siddhey LLC
Diabetic Foot Ulcer
Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers
This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating diabetic foot ulcers.
- Trial name
- NCT06938685
- Testing
- Standard of Care, NeoThelium FT
- Where
- 8 sites in United States
- Volunteers
- 132 people
- Sponsor
- NuScience Medical Biologics, LLC