Clinical trials: Foot Ulcer, Diabetic
Real Life Study, TLC-NOSF Dressings
Clinical Evaluation in Real Life of TLC-NOSF Dressings in the Local Treatment of Chronic Wounds (DFU and VLU)
The objective of this study is to document the performance and the safety of UrgoStart Plus® Border, UrgoStart Plus® Pad and UrgoStart Interface® in the local treatment of diabetic foot ulcers (neuropathic or neuroischemic …
- Conditions
- Real Life Study, TLC-NOSF Dressings, Venous Leg Ulcer, Diabetic Foot Ulcer
- Trial name
- STARTLIFE (NCT06135987)
- Testing
- TLC-NOSF dressings (D'URGOSTART PLUS® BORDER, URGOSTART PLUS® PAD and URGOSTART INTERFACE®)
- Where
- France
- Volunteers
- 600 people
- Sponsor
- Laboratoires URGO
Diabetic Foot Ulcer
Prospective, Multicenter, RCT of the Tenex Ultrasound System
The goal of this multicenter randomized controlled trial is compare standard of care (SOC) to Tenex MicroTip ultrasound therapy plus SOC in patients with Wagner 1-2 diabetic foot ulcers.
- Trial name
- NCT06137222
- Testing
- Tenex TXB MicroTip Ultrasound system plus SOC, Standard of Care for diabetic foot ulcer
- Where
- 2 sites in United States
- Volunteers
- 148 people
- Sponsor
- Tenex Health Inc.
Pressure Ulcer, Diabetic Foot Ulcer
Efficacy of Wound Dressings With Copper Oxide
Thirty patients of 18-85 years of age, with 2-30 cm2 pressure ulcers or post-op wounds, will be recruited and treated with either wound dressing containing silver or wound dressings containing copper oxide microparticles.
- Trial name
- NCT04634838
- Testing
- MedCu Antibacterial Wound Dressings with Copper Oxide
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- MedCu Technologies Ltd.
Wounds and Injuries, Negative Pressure Therapy
Comparison of Wound Healing Between MedCu Dressings With Copper Oxide and Negative Pressure Wound Therapy Treatment
Randomized multisite two arms study in which one arm of patients will be treated with Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm") and the second arm of patients will be…
- Conditions
- Wounds and Injuries, Negative Pressure Therapy, Diabetic Foot Ulcer
- Trial name
- NCT05215730
- Testing
- MedCu wound dressings with copper oxide (COD)
- Where
- Israel
- Volunteers
- 46 people
- Sponsor
- MedCu Technologies 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
Diabetic Foot Ulcer
High Intensity LED Photobiomodulation Therapy for Chronic Leg and Foot Ulcers
Diabetic and venous ulcers affect many people, and severe cases can end up in amputation and even death because of infection. In 2011, the total cost for care of diabetic foot ulcers alone, to the Canadian health care system, was…
- Trial name
- NCT04300205
- Testing
- High intensity LED light device
- Where
- Canada
- Volunteers
- 33 people
- Sponsor
- Illumacell Inc.
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
Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers
The purpose of the following prospective, randomized, controlled clinical trial is to compare synthetic hybrid-scale fiber matrix (Restrata®, Acera Surgical, Inc.) with standard of care in treating diabetic foot ulcers in human…
- Trial name
- NCT04918784
- Testing
- Restrata®, Wound Dressing
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Acera Surgical, Inc.
Diabetic Foot Ulcer, Venous Leg Ulcer
Efficacy and Tolerance of URGO AWC_008 and URGO AWC_022 Dressings (EXPANSION)
Evaluation of the efficacy (wound epithelialization and time to closure) and tolerance (emergence and nature of adverse event) of the new URGO AWC_008 and URGO AWC_022 dressings in local management of acute and chronic wounds at…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Wound Infection
- Trial name
- NCT05772507
- Testing
- URGO AWC_008 dressing or URGO AWC_022 dressing
- Where
- France
- Volunteers
- 85 people
- Sponsor
- Laboratoires URGO
Diabetic Foot Ulcer
Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers
The purpose of the current Study is to determine the safety and effectiveness of Galnobax® plus Standard of Care versus only Standard of Care, in treating Diabetic Foot Ulcers (DFU).
- Trial name
- NCT03998436
- Testing
- Esmolol Hydrochloride, Only Standard of Care, Vehicle Gel
- Where
- 14 sites in India
- Volunteers
- 176 people
- Sponsor
- Novalead Pharma Private Limited
Diabetic Foot Ulcer, Non-healing Diabetic Foot Ulcer
EPC Silver Wound Gel (EPC-123) Feasibility Study in the Management of Mildly Infected Diabetic Foot Ulcers
The objective of this single-arm feasibility study is to investigate the safety and impact of the topical EPC Silver Wound Gel (EPC-123) in the management of diabetic foot ulcer wounds not progressing under the current standard…
- Conditions
- Diabetic Foot Ulcer, Non-healing Diabetic Foot Ulcer, Diabetic Foot Infection
- Trial name
- NCT05243810
- Testing
- EPC Silver Wound Gel
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Exciton Technologies Inc.
Non-healing Wound, Diabetic Foot Ulcer
Use of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers
The purpose of this clinical evaluation is to collect and compare outcomes data from patients with UT 1A diabetic foot ulcers treated with 510K FDA cleared, commercially available self-assembling peptide, AC5®Advanced Wound…
- Trial name
- NCT06028386
- Testing
- AC5® Advanced Wound System, Fibracol Plus Collagen Dressing
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Arch Therapeutics
Venous Leg Ulcer, Pressure Ulcer
Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems
The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in…
- Conditions
- Venous Leg Ulcer, Pressure Ulcer, Diabetic Foot Ulcer, Chronic Ulcer
- Trial name
- ASOLO-CW (NCT04753294)
- Testing
- Avance Solo NPWT System, Avance Solo Adapt NPWT System
- Where
- 13 sites in Belgium, Denmark and 5 more
- Volunteers
- 136 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot, Ulcer Foot
SDRM® vs. Collagen for Diabetic Foot Ulcers
Supra SDRM® is FDA-cleared as a dressing for treating partial and full-thickness wounds. It is a dermal substitute that provides a barrier and an ECM-like structure to help accelerate wound healing.
- Conditions
- Diabetic Foot, Ulcer Foot, Wound Heal
- Trial name
- NCT05883098
- Testing
- Wound debridement, Wound closure matrix application
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Polymedics Innovations Inc.
Diabetic Foot Ulcer
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-201 Clinical Trial
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-DFU-201) for 23 months.
- Trial name
- NCT03183804
- Testing
- ALLO-ASC-DFU, Standard therapy
- Where
- 4 sites in South Korea
- Volunteers
- 54 people
- Sponsor
- Anterogen Co., Ltd.
Diabetic Foot Ulcer
Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers.
This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to placebo therapy.
- Trial name
- NCT03370874
- Testing
- ALLO-ASC-DFU, Vehicle sheet
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- Anterogen Co., Ltd.
Diabetic Foot Ulcer
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-301 Clinical Trial
This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) for 24 months
- Trial name
- NCT04590703
- Testing
- ALLO-ASC-DFU, Vehicle sheet
- Where
- 8 sites in South Korea
- Volunteers
- 73 people
- Sponsor
- Anterogen Co., Ltd.
Diabetic Foot Ulcer
Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers
This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Wagner Grade II Foot Ulcers, compared to placebo therapy.
- Trial name
- NCT04497805
- Testing
- ALLO-ASC-SHEET
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Anterogen Co., Ltd.
Diabetic Foot Ulcer
TWB-103 for Treating Lower Limb Ulcers on Patients With DM
Primary Objective: To assess the safety profile of TWB-103 administered to subjects with diabetic lower limb ulcers Secondary Objective: To explore the efficacy of TWB-103 administered to subjects with diabetic lower limb ulcers
- Trial name
- NCT03624023
- Testing
- TWB-103
- Where
- 2 sites in Taiwan
- Volunteers
- 10 people
- Sponsor
- Transwell Biotech Co., Ltd.
Diabetic Foot Ulcer
Nitric Oxide Footbath for Treatment of Diabetic Foot Ulcers
The purpose of this study is to investigate the safety and effectiveness of a nitric oxide releasing solution, delivered as a footbath, to act as an antimicrobial treatment for participants presenting with a diabetic foot ulcer.
- Trial name
- NCT04755647
- Testing
- Nitric Oxide-Releasing Solution, Saline solution, hypotonic
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Sanotize Research and Development corp.