Clinical trials: Non-Healing Ulcer of Skin
Diabetic Foot Ulcers (DFUs)
Clinical Trial Evaluating an Amnion Membrane Allograft for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care
The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with Standard of Care (SOC) versus FIBRACOL™ with SOC.
- Trial name
- NCT06767501
- Testing
- E-GRAFT ™, FIBRACOL™
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Skye Biologics Holdings, LLC
Venous Leg Ulcer
Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01)
It is hypothesized that application at 4-week intervals of the human umbilical cord tissue TTAX01 to the surface of a well debrided, nonhealing venous leg ulcer (VLU) will result in a high proportion of wounds showing complete…
- Trial name
- NCT03818828
- Testing
- TTAX01, Profore Compression Therapy, Cadexomer Iodine dressing
- Where
- 6 sites in United States
- Volunteers
- 31 people
- Sponsor
- BioTissue Holdings, Inc
Foot Ulcer, Diabetic
NEOX® CORD 1K vs Standard of Care in Non-healing Diabetic Foot Ulcers
In this randomized, multi-center, cross-over study, the efficacy and safety of NEOX® CORD 1K will be evaluated in patients suffering from non-healing diabetic foot ulcers.
- Trial name
- CONDUCT I (NCT02166294)
- Testing
- NEOX® CORD 1K, Standard of Care (Pressure Bandage)
- Where
- 3 sites in United States
- Volunteers
- 18 people
- Sponsor
- Amniox Medical, Inc.
Diabetic Foot Ulcer
Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers
A Prospective, Double-blind, Multi-center, Randomized, Parallel-group safety and efficacy study of adipose-derived regenerative cells (ADRCs) in the treatment of patients with diabetic foot ulcers (DFU).
- Trial name
- ASCEND (NCT05095389)
- Testing
- ADRCs, standard care
- Volunteers
- 290 people
- Sponsor
- Paracrine, INC.
Non-healing Wound
Treatment of Wounds Using Oasis® ECM
The purpose of this clinical study is to gather post-market clinical evidence on the use of Oasis ECM as a treatment for donor site wounds in the community setting in the United Kingdom.
- Trial name
- NCT03632031
- Testing
- Oasis Extracellular Matrix, Standard Care (in control arm)
- Where
- 2 sites in United Kingdom
- Volunteers
- 41 people
- Sponsor
- Cook Biotech Incorporated
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
Non-Healing Ulcer of Skin, Non-healing Wound
A Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers
The purpose of this research is to explore the use of high-resolution microvessel ultrasound imaging system to look for scarring and to monitor wound healing and to see if treatment affects the amount of tiny vessels and…
- Conditions
- Non-Healing Ulcer of Skin, Non-healing Wound, Lower Extremity Wound
- Trial name
- NCT05739149
- Testing
- Microvessel Ultrasound Examination, Skin Biopsy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Mayo Clinic
Diabetic Foot Ulcer
RESPOND Restoring Equilibrium and Wound Stimulation to Promote Healing Of Non-healing DFUs
To evaluate the safety and effectiveness of MIST Therapy in conjunction with Standard of Care (SOC) compared to Standard of Care alone in the treatment of diabetic foot ulcers (DFU).
- Trial name
- NCT01608776
- Testing
- MIST Therapy, SOC - Standard of Care
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Celleration, Inc.
Varicose Ulcer
MIST Ultrasound Therapy Compared to United Kingdom Standard Care for the Treatment of Non-healing Venous Leg Ulcers
Chronic venous leg ulcers (VLUs) impact negatively on patients' quality of life. Standard treatment in the UK for patients with VLUs is compression bandaging or stockings.
- Trial name
- NCT01671748
- Testing
- MIST ultrasound therapy, Standard Care
- Where
- United Kingdom
- Volunteers
- 47 people
- Sponsor
- Cardiff and Vale University Health Board
Venous Leg Ulcer
Clinical Study Of Affinity Versus SOC In The Management Of VLUs
This prospective, multi-center, randomized, controlled clinical study compares Affinity® plus SOC to SOC alone in subjects with VLUs.
- Trial name
- NCT04901013
- Testing
- Affinity
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Organogenesis
Venous Insufficiency, Venous Reflux
Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers
This trial is a prospective, randomized, controlled, multi-center study of subjects presenting with chronic lower extremity venous ulcers.
- Conditions
- Venous Insufficiency, Venous Reflux, Lower Extremity Ulcer
- Trial name
- NCT01549860
- Testing
- MIST Therapy
- Where
- United States
- Volunteers
- 156 people
- Sponsor
- Celleration, Inc.
Foot Ulcer, Diabetic
Use of Procenta® Conformable Barrier for Non-Healing Foot & Ankle Ulcers in Patients With Diabetes Mellitus Types I and II
Procenta® has been successful in facilitating closure of non-healing diabetic ulcers in patients where proper wound care management/practice has failed along with other allo- and xenografts.
- Trial name
- Procenta (NCT05099887)
- Testing
- Procenta conformable barrier
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- The VA Western New York Healthcare System
Diabetic Foot Ulcers, Diabetic Wound
The Effect of Platelet-Rich Plasma-Fibrin Glue in Combination With Vitamin E and C for Treatment of Non-healing Diabetic Foot Ulcers
The aim of this study is to evaluates the chance of non-healing Diabetic Foot Ulcers repair by reducing oxidative stress caused by diabetes by taking vitamin E and C supplements along with the use of Platelet-Rich Plasma-Fibrin…
- Trial name
- NCT04315909
- Testing
- PRP-Fibrin Glue, Vitamin E and C
- Where
- Iran
- Volunteers
- 24 people
- Sponsor
- Mashhad University of Medical Sciences
Diabetic Foot Ulcers (DFUs)
Effect of Meso Wound Matrix in the Treatment of DFUs
This is a prospective trial designed to evaluate the use of Meso Wound Matrix (DSM Biomedical, Exton, PA) in Wagner grade 1 and 2 DFUs.
- Trial name
- NCT04182451
- Testing
- Meso Wound Matrix
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- SerenaGroup, Inc.
Type2diabetes, Foot Ulcer
Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers
The goal of this study is to improve the therapeutic management of diabetic foot ulcers (DFU). The main questions to answer are if a program of non-weight bearing exercise helps the DFU heal faster than standard wound care.
- Trial name
- NCT05603273
- Testing
- non-weight bearing exercise
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Michigan
Varicose Ulcer
A Post-Marketing Clinical Study of Apligraf for Venous Leg Ulcers
Single site clinical study utilizing the novel technology of microarrays to identify and characterize the molecular mechanisms through which Apligraf promotes healing of venous leg ulcers.
- Trial name
- NCT00648674
- Testing
- Apligraf
- Sponsor
- Organogenesis
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
Leg Ulcers Venous, Dehiscence, Surgical Wound
Blu Light for Ulcers Reduction
Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks.
- Trial name
- BLUR (NCT04018924)
- Testing
- Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)
- Where
- 7 sites in Italy
- Volunteers
- 90 people
- Sponsor
- Emoled
Non-Healing Ulcer of Skin, Autofluorescence Imaging
Retrospective Database Review at LTC and SNFs
The goal of this observational study is to compare the differences in wound outcomes when the MolecuLight imaging procedure is used in combination with standard of care wound assessment in long term care and skilled nursing…
- Trial name
- NCT06068972
- Testing
- MolecuLight
- Where
- United States
- Volunteers
- 193 people
- Sponsor
- Wound Care Plus, LLC