Clinical trials: Diabetic Feet
Diabetic Foot Ulcer, Diabetic Foot Ulcer (DFU)
Study to Assess Remote Imaging System to Monitor Diabetic Foot Ulcers
The goal of this observational pilot study is to evaluate whether a new remote monitoring platform (TASHA) can support accurate and reliable assessment of diabetic foot ulcers in adult patients receiving care in a UK NHS clinic.
- Trial name
- NCT07013448
- Testing
- Foot scan
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Medical Intelligence Group
Painful Diabetic Neuropathy, Diabetes
A Safety Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Painful Diabetic Neuropathy
Study CLO-311 is a multicenter, open-label, single-arm study to assess the long-term use of Clonidine Gel in the treatment of pain associated with PDN.
- Trial name
- NCT02355158
- Testing
- clonidine hydrochloride topical gel, 0.1%
- Where
- 20 sites in United States
- Volunteers
- 197 people
- Sponsor
- BioDelivery Sciences International
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
Diabetic Foot Infection, Non-healing Wound
Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)
It is hypothesized that application at 4-week or greater intervals of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer (DFU) will, with concomitant management of…
- Conditions
- Diabetic Foot Infection, Non-healing Wound, Non-healing Diabetic Foot Ulcer
- Trial name
- NCT04450693
- Testing
- TTAX01, Standard care
- Where
- 16 sites in United States
- Volunteers
- 106 people
- Sponsor
- BioTissue Holdings, Inc
Diabetic Foot Ulcers
Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic Foot Ulcers
This is a Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the clinical efficacy and safety of Antimicrobial Peptide PL-5 Topical Spray in patients with mild infections of diabetic foot…
- Trial name
- PL-5 (NCT06189638)
- Where
- 3 sites in United States
- Volunteers
- 90 people
- Sponsor
- Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.
Chronic Wounds, Venous Leg Ulcers (VLUs)
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
Chronic wounds constitute a significant global health burden, affecting millions of individuals and contributing to increased morbidity, diminished quality of life, and rising healthcare costs.
- Conditions
- Chronic Wounds, Venous Leg Ulcers (VLUs), Diabetic Foot Ulcers (DFUs), Arterial Ulcers
- Trial name
- NCT07223892
- Testing
- Amniotic Tissue Allograft
- Volunteers
- 600 people
- Sponsor
- Bardia Anvar
Foot Ulcer, Diabetic
The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial
The primary aim of this study proposal is to test an innovative form of fetal bovine dermis bioscaffold in combination with negative pressure wound therapy (NPWT) to enhance wound healing in diabetic foot ulcers.
- Trial name
- NCT01228500
- Testing
- PriMatrix
- Where
- United States
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcer, Venous Leg Ulcer
Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.
- Trial name
- NCT06236750
- Testing
- EPIFIX
- Where
- 5 sites in Japan
- Volunteers
- 75 people
- Sponsor
- MiMedx Group, Inc.
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
Diabetic Foot Ulcer
A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers
This prospective, multi-center, randomized, controlled modified platform Trial compares Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care versus…
- Trial name
- PREPARE (NCT06618612)
- Testing
- Standard of Care, PuraPly AM, PuraPly XT
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Organogenesis
Diabetic Foot Ulcers
Evaluation of Woulgan in Diabetic Foot Ulcer
The aim of the current study is to support the performance and safety of Woulgan® in the treatment of diabetic foot ulcer in comparison with the commercially available hydrogel Intrasite.
- Trial name
- NCT02631512
- Testing
- Woulgan Gel, Intrasite Hydrogel
- Where
- 3 sites in Sweden, United Kingdom
- Volunteers
- 62 people
- Sponsor
- Biotec Pharmacon ASA
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing
The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics…
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU), Pressure Ulcer (PU)
- Trial name
- RETRO-PLAST (NCT07375160)
- Testing
- dHPT, AIC
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Cellution Biologics
Diabetic Foot Ulcer
Study of the Efficacy of PedyPhar® Ointment on the Diabetic Foot Ulcers
Clinical Trial Phase III-b Study Sponsor: European Egyptian Pharmaceutical Industries Sample Size: 120 patients (60 per arm) Study Population: Patients with Diabetic foot ulcer of any stage after proper surgical treatment - if…
- Trial name
- PED111 (NCT01531517)
- Testing
- Royal Jelly and Panthenol (PedyPhar® Ointment), Panthenol Ointment
- Where
- 2 sites in Egypt
- Volunteers
- 47 people
- Sponsor
- European Egyptian Pharmaceutical Industries
Diabetic Foot Ulcer
The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers
The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard daily wound care and an oral antibiotic (levofloxacin) is safe and effective in treating moderately infected skin ulcers…
- Trial name
- NCT00659646
- Testing
- gentamicin-collagen sponge and levofloxacin, Levofloxacin only
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Innocoll
Diabetic Foot Ulcer
The Purpose of This Study is to Assess Clinical Efficacy and Safety of Berovenal® Intended to Promote Treatment and to Expedite Chronic Diabetic Foot Ulcer Healing
The goal of this clinical investigation is to evaluate clinical efficacy of medical device Berovenal® intended to promote treatment and to expedite healing of chronic diabetic foot ulcer in male or female subjects aged 18-85…
- Trial name
- NCT06584617
- Testing
- Berovenal®, NU-GEL Hydrogel with Alginate
- Where
- 9 sites in Germany, Poland
- Volunteers
- 66 people
- Sponsor
- VULM s.r.o.
Diabetic Foot, Foot Ulcer, Diabetic
Use of Santyl in Diabetic Foot Ulcers
This study is designed to test the hypothesis that daily treatment of diabetic foot ulcers with an enzymatic debriding agent, SANTYL, for up to 6 weeks will result in more rapid decrease in ulcer area than diabetic foot ulcers…
- Trial name
- NCT02581488
- Testing
- Santyl, Product containing silver
- Where
- 13 sites in United States, Canada
- Volunteers
- 102 people
- Sponsor
- Smith & Nephew, Inc.
Foot Ulcer, Diabetes Mellitus
Efficacy Of CACIPLIQ20 On Diabetic Ulcers In Patients Wearing An Nonremovable, Windowed, Fiberglass Cast Boot
CACIPLIQ20 is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Glycosaminoglycans are implied 1) in the stabilization of the micro-environment of cells, known as extracellular matrix, by binding to…
- Conditions
- Foot Ulcer, Diabetes Mellitus, Diabetic Neuropathy
- Trial name
- DIAPLIQ (NCT01474473)
- Testing
- CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast Boot
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Organ, Tissue, Regeneration, Repair and Replacement
Pathologic Processes, Diabetes Mellitus
Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs
The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers…
- Conditions
- Pathologic Processes, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases
- Trial name
- C5CAMP (NCT06674980)
- Testing
- Standard of Care - DFU, AM/Single - DFU, AM/Double - DFU
- Where
- United States
- Volunteers
- 177 people
- Sponsor
- C5 Biomedical
Lower Extremity Chronic Ulcers in Diabetics, Diabetic Foot Ulcer (DFU)
Artacent Amniotic Tissue for Treatment of Chronic Lower Extremity Diabetic Ulcers.
This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period.
- Trial name
- NCT07219004
- Testing
- amniotic membrane
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Tides Medical
Peripheral Diabetic Neuropathy, Painful Diabetic Neuropathy
Observational Study to Evaluate the Efficacy of Sustained QUTENZA® Use in Painful Diabetic Peripheral Neuropathy
The purpose of this post-market observational study is to provide real-world evidence to support the repeated use of QUTENZA in patients with PDPN and to evaluate the potential for pain and concomitant medication use reduction.
- Trial name
- NCT06495424
- Testing
- Capsaicin 8%
- Where
- 10 sites in United States
- Volunteers
- 144 people
- Sponsor
- Averitas Pharma, Inc.