Clinical trials: Chronic Foot Ulcers
Wound Healing, Diabetic Foot
Clinical Study Evaluating Wound Closure With Endoform™ and Symphony™
Study will evaluate the performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with Symphony™ in the treatment of chronic non-healing diabetic foot ulcers after 12 weeks of treatment.
- Conditions
- Wound Healing, Diabetic Foot, Chronic Foot Ulcer, Foot Ulcer
- Trial name
- NCT06035523
- Testing
- Endoform™ Antibacterial, Endoform™ Natural, Symphony™
- Where
- 4 sites in United States
- Volunteers
- 44 people
- Sponsor
- Aroa Biosurgery Limited
Diabetic Foot Ulcer (DFU), Granulation of Chronic Diabetic Wounds
Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue
The objective of this study is to evaluate the safety and efficacy of VELGRAFT in patients with chronic diabetic foot ulcers, which have attained granulation tissue.
- Trial name
- NCT07498218
- Testing
- an allogenic cell-based product, containing living human bone marrow-derived mesenchymal stem cells (MSCs) and MSCs differentiated into adipocytes on a porous chitosan-gelatin matrix, Standard of Care of Diabetic Foot Ulcers
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Ayu, Inc.
Diabetic Foot Ulcer (DFU), Chronic Foot Ulcers
Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers
The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in…
- Trial name
- NCT06681428
- Testing
- Allograft
- Where
- 9 sites in United States
- Volunteers
- 240 people
- Sponsor
- Tides Medical
Skin Ulcer
Bio-ConneKt Wound Dressing for Treatment of Chronic Leg Wounds: A Pilot Study
The purpose of this study is to assess the performance of the bio-ConneKt™ wound dressing and compare its performance with the standard of care at NFRMC Wound Therapy Services, for the treatment of chronic foot/leg ulcers…
- Trial name
- NCT02309684
- Volunteers
- 20 people
- Sponsor
- MLM Biologics Inc.,
Foot Ulcer, Diabetic
GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers
The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.
- Trial name
- NCT02675855
- Testing
- GrafixPRIME®, Dressing Application, Off-loading (walking boot)
- Where
- 3 sites in United States
- Volunteers
- 75 people
- Sponsor
- Osiris Therapeutics
Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)
INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm
This prospective observational study will collect routine clinical waste material from 72 adults with chronic, non-healing wounds, including wound exudate from negative pressure therapy containers or sponges and wound…
- Trial name
- INJECTHEAL (NCT07745764)
- Testing
- standard of care
- Where
- Germany
- Volunteers
- 72 people
- Sponsor
- Barbara Wolff-Winiski
Ulcer, Venous Ulcer
ECM and Blood Components for Wound Healing
The Extracellular Matrix (ECM) and Blood Components for Wound Healing feasibility study is a clinical trial approved by Health Canada to study the safety of extracellular matrix (ECM) and autologous blood products in wound…
- Conditions
- Ulcer, Venous Ulcer, Foot Ulcer, Diabetic
- Trial name
- NCT01909908
- Testing
- ECM, Blood Products, ECM in Blood Products
- Where
- Canada
- Volunteers
- 2 people
- Sponsor
- Cook Group Incorporated
Diabetic Foot, Chronic Ulcer
Safety and Efficacy of ActiGraft Pro Compared to Standard of Care in DFUs
The study is a multi-center, prospective, randomized, controlled, single blinded clinical study consisting of 150 subjects from up to 20 centers.
- Trial name
- NCT04185558
- Testing
- ActiGraft, Standard of Care
- Where
- 16 sites in United States, South Africa and 1 more
- Volunteers
- 119 people
- Sponsor
- RedDress Ltd.
Diabetic Foot Ulcers
Grafix® DFU: Open-Label Extension Option to Evaluate Safety & Efficacy of Grafix® for Chronic Diabetic Foot Ulcers
The primary objective of the present study is to further establish in a randomized controlled trial, the safety and efficacy of weekly Grafix® administration versus control in patients with chronic diabetic foot ulcers.
- Trial name
- DFU (NCT01596920)
- Testing
- Tissue, Control
- Where
- 15 sites in United States
- Volunteers
- 97 people
- Sponsor
- Osiris Therapeutics
Diabetic Foot Ulcer, Venous Leg Ulcer
The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds
This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers.
- Trial name
- SPACE (NCT05666570)
- Testing
- Avelle NPWT
- Where
- Colombia
- Sponsor
- ConvaTec Inc.
Diabetic Foot, Chronic Foot Ulcer
Randomized Clinical Study Comparing SynPath to Standard of Care in Treatment of Chronic Diabetic Foot Ulcers
The study will evaluate the efficacy of SynPath™, a synthetic dermal matrix, in the treatment of diabetic foot ulcers in subjects with diabetes mellitus versus Standard of Care treatment.
- Conditions
- Diabetic Foot, Chronic Foot Ulcer, Wound Healing, Foot Ulcer
- Trial name
- DFUs (NCT05506215)
- Testing
- SynPath Acellular Dermal Matrix plus Off-loading Device, Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading Device
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- PolyNovo Biomaterials Pty Ltd.
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
Diabetic Foot Ulcer
Safety and Efficacy Study of APIC-PRP in Non-healing Diabetic Foot Ulcers
Patients have a diabetic foot ulcer that is older than 4 weeks and has been treated with physician-selected standard of care treatment such as debridement, hydrogel or saline irrigation, primary dressing, and offloading will be…
- Trial name
- NCT02209662
- Testing
- APIC-PRP
- Volunteers
- 274 people
- Sponsor
- Cytonics Corporation
Diabetic Foot Ulcer
NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers (NTCDU)
The goal of this multi-center,randomized, placebo controlled, evaluator-blinded study is to assess the efficacy and safety of NOX1416 in the treatment of chronic, non-healing, diabetic foot ulcers (DFUs).
- Trial name
- NTCDU (NCT06020664)
- Testing
- NOX-1416+SOC
- Where
- 6 sites in Israel
- Volunteers
- 30 people
- Sponsor
- NOxy Health Products, LLC
Diabetic Foot, Diabetic Foot Ulcer
Study for Treatment of Chronic Diabetic Foot Ulcers With the Investigational Allogeneic Cell Therapy Product, hOMSC200
Purpose of this phase 1/2a study is to assess the safety and efficacy of administration of allogeneic human oral mucosal stem cells (hOMSCs) in patients suffering from chronic diabetic foot ulcers (DFU).
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic
- Trial name
- NCT06003530
- Testing
- hOMSC200
- Where
- Israel
- Volunteers
- 21 people
- Sponsor
- Cytora Ltd.
Foot Ulcer, Diabetic
Evaluation of a Medical Food for Chronic Wounds
The study objective is to compare outcomes in subjects with a diabetic foot ulcer after 16 weeks of consuming a medical food versus a calorically similar control drink.
- Trial name
- NCT00711217
- Testing
- Medical Food, Drink mix calorically similar to experimental product
- Where
- 51 sites in United States, Spain and 2 more
- Volunteers
- 271 people
- Sponsor
- Abbott Nutrition
Diabetic Foot Ulcer, Type 1 Diabetes Mellitus
Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.
The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care for both males and females, ages 18-80 years old, with Grade 1 and 2…
- Conditions
- Diabetic Foot Ulcer, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM), Neuroischemic Foot Ulcer
- Trial name
- NCT06810726
- Testing
- Platelet Rich Plasma
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Estar Medical dba Medical Technologies, LTD
Diabetic Foot Ulcer (DFU), Amnio-Maxx
Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
- Trial name
- NCT07209475
- Testing
- Amnio-Maxx® Dual Layer Amnion Patch, Standard of Care (Investigator Choice)
- Where
- 8 sites in United States
- Volunteers
- 248 people
- Sponsor
- Royal Biologics
Chronic Wounds
Swab Sample Collection for the Detection of Bacterial Proteases
The objective of this study is to collect wound exudate (fluid) swab samples from Subjects who have wounds that show clinical signs of infection, as well as from Subjects who have wounds that do not show clinical signs of…
- Trial name
- NCT01881815
- Testing
- Swabs
- Where
- United States
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Systagenix Wound Management
Diabetic Foot Ulcer (DFU), Diabetic Foot Ulcer Treatment
CHEMfoot: DEBRICHEM® in Chronic Diabetic Foot Wounds
This multicenter, randomized controlled trial will evaluate the effectiveness and safety of DEBRICHEM®, a topical desiccant gel, when added to standard care for chronic diabetic foot wounds.
- Conditions
- Diabetic Foot Ulcer (DFU), Diabetic Foot Ulcer Treatment, Diabetic Foot Wounds
- Trial name
- CHEMfoot (NCT07206862)
- Testing
- DEBRICHEM®
- Volunteers
- 242 people
- Sponsor
- DEBx Medical B.V.