Clinical trials: Foot Injuries and Disorders
Diabetic Foot Ulcer (DFU)
CARE-D-FOOT-Nav Pilot
This pilot study aims to examine the implementation of a patient navigator intervention called Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav).
- Trial name
- NCT07143175
- Testing
- Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Emory University
Diabetic Foot Ulcer
Low Level Laser Therapy and Expression of VEGF, NO, VEGFR-2, HIF-1α in Diabetic Foot Ulcers
The purpose of this study is to examine the changes of factors including Vascular Endothelial Growth Factor(VEGF), VEGFReceptor-2, Nitric Oxide and hypoxia-inducible factor-1α (HIF-1α), measurements of oxygen saturation in…
- Trial name
- NCT02452086
- Testing
- Low Level Laser(Ga-As)
- Where
- Iran
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Tarbiat Modarres University
Diabetic Foot Ulcer
Ultrasound Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU)
The investigators aimed to elucidate the effects of UAW debridement on cellular proliferation and dermal repair in complicated diabetic foot ulcers as compared to diabetic foot ulcers receiving surgical/sharp wound debridement.
- Trial name
- NCT04633642
- Testing
- Ultrasound group, Surgical group
- Where
- 2 sites in Spain
- Volunteers
- 51 people
- Sponsor
- Universidad Complutense de Madrid
Diabetic Foot Ulcer
A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AC
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amnion Chorion (BR-AC) plus standard of care versus standard of care only in the treatment of diabetic foot…
- Trial name
- NCT06511596
- Testing
- BR-AC, Standard Care
- Where
- 11 sites in United States
- Volunteers
- 71 people
- Sponsor
- BioStem Technologies
Diabetic Foot Ulcer
Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds
This is an IRB-approved multicenter study.This non-inferiority study aims to evaluate differential healing rates between Lavior Diabetic Wound Gel and other Hydrogels.
- Trial name
- RENEW (NCT05607979)
- Testing
- Lavior Diabetic Wound Gel, Smith & Nephew Solosite Gel Hydrogel Wound Dressing
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Lavior Pharma Inc.
Chronic Diabetic Foot Ulcers
Shockwave Treatment of Diabetic Foot Ulcer: Step I
Extracorporeal Shock Wave treatment is a well established treatment in orthopedics. Considerable success has been reported after treatment of various soft tissue pathologies (Tendinitis, heel spur etc).
- Trial name
- STUF (NCT00954343)
- Testing
- Extracorporeal Shock Wave
- Where
- Germany
- Sponsor
- Technical University of Munich
Ankle and Hindfoot Arthrodesis
Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft
The objective of this long-term study is to evaluate the long-term effectiveness and safety of AUGMENT® Injectable Bone Graft vs. autologous bone graft.
- Trial name
- NCT03998137
- Testing
- AUGMENT® Injectable Bone Graft, Standard of Care
- Volunteers
- 94 people
- Sponsor
- BioMimetic Therapeutics
Ankle Injuries, Foot Injuries and Disorders
Weight Change With Controlled Ankle Movement (CAM) Boot Use
The purpose of the study is to determine if patients wearing a CAM boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional guidelines and perform upper body exercises.
- Conditions
- Ankle Injuries, Foot Injuries and Disorders, Body Weight Changes
- Trial name
- CAM (NCT05692401)
- Testing
- Nutrition and Exercise Instruction
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Nell Blake, DPM
Diabetic Foot Ulcer, Venous Leg Ulcer
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care.
- Trial name
- NCT04927702
- Testing
- Synthetic Hybrid-Scale Fiber Matrix, Standard of Care, Living Cellular Skin Substitute
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Acera Surgical, Inc.
Foot Ulcer, Diabetic
Negative Pressure Wound Therapy as a Drug Delivery System (ADANPWT)
The investigators plan a randomized clinical trial of 150 patients with infected diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of negative pressure wound therapy with continuous…
- Trial name
- ADA NPWT (NCT02308800)
- Testing
- Quantum™ Therapy - NPWT with Prontosan, Quantum™ Therapy
- Where
- United States
- Sponsor
- University of Texas Southwestern Medical Center
Surgical Incision, Ulcer Foot
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot…
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg
- Trial name
- PICO14 (NCT05234632)
- Testing
- PICO 14 single-use Negative Pressure Wound Therapy System
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcer, Healing Delayed
Mean Healing Time of Wound After Vacuum Assisted Closure (VAC) Versus Conventional Dressing in Diabetic Foot Ulcer Patients
Comparison the mean healing time of wound after vacuum assisted closure(VAC) versus conventional dressing(CD) in diabetic foot ulcer(DFU) patients.
- Conditions
- Diabetic Foot Ulcer, Healing Delayed, Wound; Foot, Diabetes Mellitus
- Trial name
- NCT04959071
- Testing
- Vacuum assisted closure VAC vs conventional dressing
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Bahria University
Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic
Diabetic Foot Ulcer Research Study
The goal of this clinical trial is to compare safety and performance of the study device to the current typical NHS standards of care device.
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic, Diabetic Foot Ulcer Ischemic
- Trial name
- NCT05762432
- Testing
- Wound Dressing, NHS Standard Dressing
- Where
- 2 sites in United Kingdom
- Volunteers
- 100 people
- Sponsor
- Community Pharmacology Services Ltd
Critical Lower Limb Ischemia, Critical Limb Ischemia
Evaluation of Carbothera in the Treatment of Foot Ulcers
Foot ulceration usually precedes more serious foot complications such as infection, gangrene or amputation. The risk of developing foot ulcers has been estimated to be higher in individuals with kidney disease.
- Conditions
- Critical Lower Limb Ischemia, Critical Limb Ischemia, Foot Ulcer, Skin Ulceration
- Trial name
- NCT02239419
- Testing
- CO2-Enriched Tap Water (Carbothera), Non-CO2-Enriched Tap Water
- Where
- 2 sites in Canada
- Volunteers
- 40 people
- Sponsor
- University of Manitoba
Diabetic Foot Ulcer, Wound Healing
Tele-Exercise Platform for Plantar Wound Healing
The purpose of the study is design and use a telemedicine platform which integrates video-chat, pre-programmed interactive game-based foot, and ankle exercise modules, and real-time quantitative performance metrics displayed to…
- Conditions
- Diabetic Foot Ulcer, Wound Healing, Wound Care
- Trial name
- Tele-FootX (NCT06439667)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Diabetes, Diabetic Foot
Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care
This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard…
- Conditions
- Diabetes, Diabetic Foot, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- Trial name
- NCT03626623
- Testing
- Cytal Wound Matrix 1-Layer, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Integra LifeSciences Corporation
Cardiovascular Diseases, Health Behavior
Influence of Walking Pilgrimage on Changes in Body Composition, Biochemical Parameters, Circulatory and Respiratory Efficiency and Foot Biomechanics in Healthy Women and Men of All Ages.
The aim of the study is to assess the health habits and changes in body composition and exercise capacity as well as blood biochemical parameters of people participating in 14-21-day walking pilgrimages.
- Conditions
- Cardiovascular Diseases, Health Behavior, Foot Injuries and Disorders, Skin Condition
- Trial name
- NCT05005832
- Testing
- multi day walking
- Where
- Poland
- Volunteers
- 30 people
- Sponsor
- Józef Piłsudski University of Physical Education
Diabetic Foot Ulcer
A RCT to Compare the Effects of Two Wound Products on Biofilm Disruption in DFUs
This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the…
- Trial name
- NCT02181621
- Testing
- Iodosorb, Solosite gel
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Smith & Nephew, Inc.
Diabetes Mellitus Foot Ulcer
Platelet Rich Plasma and Autologous Fat Graft for Diabetic Ulcer
Conventional management of diabetic ulcers is associated with slow healing, high costs and repeated trips to clinic. Stem cells contained in fat grafts can differentiate into pro-healing cells and release growth factors with…
- Trial name
- NCT03085550
- Testing
- Fat grafting, Fat grafting + platelet rich plasma
- Where
- United Kingdom
- Volunteers
- 18 people
- Sponsor
- University College, London
Diabetic Foot Ulcer
Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers
The purpose of this study is to determine whether a weekly application of EpiFix human amniotic membrane is more effective than a biweekly application (every two weeks) in the treatment of diabetic foot ulcers.
- Trial name
- NCT01657474
- Testing
- Weekly application of EpiFix plus standard of care, Biweekly application of EpiFix plus standard of care
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- MiMedx Group, Inc.