Clinical trials: Diabetic Feet
Diabetic Foot Ulcer, Dehiscence of Amputation Stump
Kerecis Omega3 Wound Plus SOC vs. SOC Alone in Treating Severe Diabetic Foot Ulcers and Forefoot Amputations
This is a prospective, multi-national, multi-centre, randomized, non-blinded (photo evaluation is blinded), controlled clinical investigation in patients suffering from diabetic wounds reaching to tendon, bone, or joint.
- Conditions
- Diabetic Foot Ulcer, Dehiscence of Amputation Stump, Amputation
- Trial name
- Odinn (NCT04257370)
- Testing
- Kerecis™ Omega3 Wound, Standard of care
- Where
- France
- Volunteers
- 260 people
- Sponsor
- Kerecis Ltd.
Diabetic Foot, Diabetic Peripheral Neuropathy
Monitoring Physiologic Parameters in Individuals With Diabetic Peripheral Neuropathy
The primary aim of this study is to use the Orpyx® SI Sensory Insole System (Orpyx Medical Technologies Inc., Calgary AB, Canada) ("Orpyx" or "the Company") as an adjunct to diabetic peripheral neuropathy standard of care (SOC)…
- Trial name
- NCT05613556
- Testing
- Orpyx SI® Sensory Insole System
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Orpyx Medical Technologies Inc.
Diabetic Foot Ulcer, Venous Leg Ulcer
ChitoCare Medical Wound Healing Gel PMCF Study on Healing of Chronic Wounds
We are testing a gel intended for the protection and healing of chronic wounds as a support for standard therapy. The main component of the gel is chitosan, a natural polymer that has the ability to stop bleeding, has a positive…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- Trial name
- CHITOCHRONIC (NCT05570877)
- Testing
- ChitoCare medical Wound Healing Gel
- Where
- 9 sites in Croatia, Slovenia
- Volunteers
- 92 people
- Sponsor
- Primex ehf
Wounds and Injuries
Managing Wounds With Allevyn Life in a Home Health Care Environment
When elderly patients need help caring for wounds, physicians may refer patients to home health care providers. The home health provider sees the patient in the patient's home and assists the patient with wound care.
- Trial name
- NCT02776800
- Testing
- Allevyn Life, Foam dressing with an integrated adhesive border
- Where
- 3 sites in United States
- Sponsor
- Smith & Nephew, Inc.
Lower Extremity Chronic Ulcers in Diabetics
Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes
Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. These ulcers are reported to be the leading cause of hospitalization among people with diabetes.
- Trial name
- NCT01421966
- Testing
- CureXcell®
- Where
- 37 sites in United States, Canada and 1 more
- Volunteers
- 285 people
- Sponsor
- Macrocure Ltd.
Diabetic Foot Ulcer
Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management
The goal of this clinical trial is to learn if use of Orion™, a dual-layer amniotic membrane allograft, in addition to standard wound care treatment can improve patient outcomes for people over the age of 50 with diabetic foot…
- Trial name
- REBOUND (NCT06420245)
- Testing
- Orion TM Amniotic Membrane Allograft, Standard of Care (SOC)
- Where
- 8 sites in United States
- Volunteers
- 240 people
- Sponsor
- Legacy Medical Consultants
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
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.
Foot Ulcer, Diabetic
Evaluation of a New Device "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients
Multi-center trial, randomized in 2 parallel groups, open label, with a blinded adjudication committee (PROBE methodology), comparing "Orthèse Diabète" with "conventional" removable devices in terms of healing of ulcers.
- Trial name
- ORTHODIAB (NCT01956162)
- Testing
- Orthèse Diabète, "Conventional" Device
- Where
- France
- Volunteers
- 118 people
- Sponsor
- Proteor Group
Foot Ulcer, Diabetic Foot
A Study on the Efficacy and Safety of Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers With REGRANEX
The purpose of this study is to evaluate the efficacy and safety of REGRANEX® Gel compared with placebo when applied for up to 52 consecutive weeks to recurring or non-healing ulcers of the ankle or foot related to diabetes.
- Conditions
- Foot Ulcer, Diabetic Foot, Skin Ulcer, Diabetic Neuropathies
- Trial name
- NCT00034788
- Testing
- Becaplermin
- Volunteers
- 84 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Non-healing Wounds
Effect of Natrox Oxygen Wound Therapy on Non-healing Wounds and Implication of Remote Monitoring and Telehealth for Management in the Home.
Single center pilot study examining the effect of Natrox topical oxygen therapy on chronic wounds along with the introduction of remote monitoring and telehealth for home care management.
- Trial name
- NCT04746573
- Testing
- Natrox Topical Oxygen Therapy
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Inotec AMD Limited
Diabetic Foot Ulcer, Chronic Ulcers of the Lower Limb
Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds
The purpose of this study is to evaluate the safety and clinical performance of transverse tibial bone transport in patients with chronic ischemic and diabetic lower extremity ulcers.
- Trial name
- NCT07444593
- Testing
- Biodynamik XT3
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Biodynamik, Inc
Infection; Diabetic Foot
Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)
This study compared ertapenem sodium to piperacillin/tazobactam sodium for the treatment of moderate to severe diabetic foot infections.
- Trial name
- NCT01370616
- Testing
- Ertapenem sodium, Piperacillin/tazobactam sodium, Amoxicillin/clavulunate potassium
- Volunteers
- 565 people
- Sponsor
- Merck Sharp & Dohme LLC
Diabetic Foot Ulcers
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers
The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).
- Trial name
- NCT01070433
- Testing
- MEBO Wound Ointment (MEBO), Standard of Care
- Where
- 9 sites in United States
- Volunteers
- 75 people
- Sponsor
- Skingenix, Inc.
Diabetic Foot Ulcer, Venous Ulcer
Wound Healing Effects of HO/03/03 In Patients With Diabetic Neuropathic Plantar and Venous Ulcers, Pilot Study.
This is a multicenter pilot study to assess the healing effects of HO/03/03 on diabetic neuropathic plantar and venous ulcers. HO/03/03 action mechanism involves the manipulation of keratinocyte and fibroblast migration and…
- Trial name
- NCT00338923
- Testing
- HO/03/03
- Where
- 3 sites in Israel
- Volunteers
- 22 people
- Sponsor
- HealOr
Foot Ulcer, Diabetic
Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix
The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects with diabetes mellitus and without…
- Trial name
- HEALED (NCT01729286)
- Testing
- PriMatrix Moist Wound Therapy, Standard of Care Moist Wound Therapy
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 92 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcers
A Randomized,Double-blind,Placebo-controlled Clinical Study to Explore the Mechanism of Action of ON101 Cream in Patients With DFUs.
The primary objective is to explore the mechanistic role of ON101 cream in healing diabetic foot ulcers by determining the molecular targets of ON101 cream.
- Trial name
- NCT04945161
- Testing
- ON101 Cream
- Where
- Taiwan
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Oneness Biotech Co., Ltd.
Diabetic Foot Infection, Non-healing Wound
Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU)
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
- NCT04176120
- Testing
- TTAX01, Standard Care
- Where
- 16 sites in United States
- Volunteers
- 220 people
- Sponsor
- BioTissue Holdings, Inc
Stage IV Pressure Ulcer, Diabetic Foot Osteomyelitis
Expanded Access Program (EAP) STIMULAN VG
Individual (single) patient expanded access may be considered.
- Trial name
- EAPSTIMVG (NCT06808568)
- Testing
- STIMULAN VG
- Sponsor
- Biocomposites Ltd
Diabetic Foot Ulcer
Treatment of Diabetic Foot Ulcers With AUP1602-C
This is a two-part phase 1/2A study performed in diabetic foot ulcer (DFU) patients with chronic non-healing wounds to investigate the safety and efficacy of AUP1602-C.
- Trial name
- NCT04281992
- Testing
- AUP1602-C
- Where
- 2 sites in Germany, Poland
- Volunteers
- 26 people
- Sponsor
- Aurealis Oy