Clinical trials: Diabetic Foot Ulcer (DFU)
Diabetic Foot Ulcer
Adjunct Collection of Additional Biorepository Data From Patients Enrolled in Diabetic Foot Consortium (DFC) Trials
The Biorepository will guide the Diabetic Foot Consortium (DFC) activities for collection and storing biosamples and data from participants enrolled in other current and future DFC research studies.
- Trial name
- NCT05092620
- Where
- 5 sites in United States
- Volunteers
- 142 people
- Sponsor
- University of Michigan
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.,
Diabetic Foot Ulcer
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)
The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™).
- Trial name
- NCT03312595
- Testing
- Restrata TM Wound Matrix
- Where
- 5 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Acera Surgical, Inc.
Diabetic Foot Ulcers
TITLE: An Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up (PMCF) Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU, When Using Mepilex Transfer Ag as Intended
An open, non-comparative, multi-centre post marketing clinical follow-up, PMCF, investigation to evaluate performance and safety on diabetic foot ulcer, dfu, when using mepilex transfer Ag as intended.
- Trial name
- MxT Ag 05 (NCT01964521)
- Testing
- Mepilex Transfer Ag
- Where
- 2 sites in United Kingdom
- Volunteers
- 24 people
- Sponsor
- Molnlycke Health Care AB
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, Peripheral Arterial Disease
A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers.
This study is evaluating whether a therapeutic ultrasound device can improve blood flow to the leg with diabetic foot ulcer (DFU).
- Conditions
- Diabetic Foot Ulcer, Peripheral Arterial Disease, Wound; Foot
- Trial name
- Dulcet (NCT05145439)
- Testing
- VibratoSleeve Therapeutic Ultrasound Device
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Vibrato Medical, Inc.
Diabetic Foot, Foot Ulcer
A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers
A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.
- Conditions
- Diabetic Foot, Foot Ulcer, Ulcer Foot, DFU
- Trial name
- NCT07159282
- Testing
- XWRAP
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Applied Biologics, LLC
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.
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
Evaluation of a Folic Acid Wound Treatment (FAWT) for Chronic, Early-Stage Diabetic Foot Ulcer (DFU) Healing
This is a twelve-week single-center, randomized, double-blind, clinical study to evaluate the safety and efficacy of a folic acid wound treatment (FAWT) versus Placebo in the promotion of healing of chronic, early stage diabetic…
- Trial name
- NCT04723134
- Testing
- Folinic acid calcium salt
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Joseph Boykin, MD
Venous Leg Ulcers, Diabetic Foot Ulcers
Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)
The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.
- Trial name
- NPWT (NCT02470806)
- Testing
- PICO System, tNPWT System
- Where
- 17 sites in United States, Canada
- Volunteers
- 164 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcer, Venous Leg Ulcer
Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs
This is a multicenter, prospective, randomized controlled modified multi-platform (matriarch) trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Ulcer Foot, Leg Ulcer
- Trial name
- NCT06560502
- Testing
- Standard of Care-DFU, AmnioCore - DFU, Amnio Quad-Core - DFU
- Where
- United States
- Volunteers
- 324 people
- Sponsor
- Stability Biologics
Diabetic Foot, Diabetic Foot Ulcer
Effectiveness of the Autologous Adipose Tissue Harvested With SEFFICARE Method for Treatment of DFU Minor Amputation
Diabetic foot ulcers (DFU) are one of the complications of diabetes mellitus resulting from multiple causes such as neuropathy, ischemia, and infection that contribute to morbidity and amputation.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Amputation
- Trial name
- SEFFIDiFA (NCT05072353)
- Testing
- SEFFICARE
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Azienda Ospedaliero-Universitaria di Modena
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.
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 Ulcers
WEMR With Clinical Decision Support for Diabetic Foot Ulcers
The goal of this project to begin using a wound research database with clinical decision support features at Winthrop University Hospital.
- Trial name
- NCT02055755
- Where
- United States
- Sponsor
- Winthrop University Hospital
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 Ulcer (DFU), Orthoses
The Effect of Using Insoles Specially Designed for Diabetic Foot on Postural Balance and Gait Parameters
Postural control and plantar pressure are affected by many parameters in diabetic individuals. It is considered important to examine the relationship between changes in plantar pressure distribution and postural balance…
- Conditions
- Diabetic Foot Ulcer (DFU), Orthoses, Postural Balance, Plantar Pressure Distrubution
- Trial name
- NCT06846476
- Testing
- Insole, Demographic Information and Anamnesis Form, Pedobarographic analysis
- Where
- Turkey (Türkiye)
- Volunteers
- 25 people
- Sponsor
- Medipol University
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