Diabetic Foot Ulcers Clinical Trial
Official title:
A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Non-Healing Diabetic Foot Ulcers
A prospective, randomized, controlled, clinical study to establish clinical based evidence of PRP Concepts Fibrin Bio-Matrix and compare its performance with the usual and customary practice for the treatment of Wagner 1 or 2 DFUs.
This is a prospective, randomized, single-blind, controlled, multi-center study for subjects undergoing DFU treatment. Qualified subjects will be randomized (1:1); test group (PRP Concepts Fibrin Bio-Matrix) and control group (usual and customary practice). The study will consist of 3 periods: a screening period, an active treatment period, and a follow-up period (if healed). Approximately 250 subjects will be enrolled. Subjects will be ≥18 years of age with a chronic Wagner grade 1 or 2 DFU (greater than 1 month duration). Each subject will be enrolled in the active treatment period for up to 12 weeks, or to closure of wound with a confirmatory visit 2 weeks after wound closure, whether such closure occurs at 12 weeks or earlier. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02652754 -
Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Diabetic Foot Ulcers
|
Phase 1 | |
| Completed |
NCT01070433 -
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers
|
Phase 2 | |
| Completed |
NCT00971048 -
Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
|
N/A | |
| Terminated |
NCT00762138 -
The AutoloGel™ Post-Market Surveillance (TAPS) Program
|
N/A | |
| Completed |
NCT00578604 -
Non-Invasive Assessment of Wound Healing With Optical Methods
|
N/A | |
| Completed |
NCT05417425 -
Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
|
Phase 1 | |
| Completed |
NCT02631512 -
Evaluation of Woulgan in Diabetic Foot Ulcer
|
Phase 4 | |
| Completed |
NCT02222376 -
Effect of Topic Pirfenidone in Diabetic Ulcers
|
Phase 3 | |
| Terminated |
NCT01816633 -
Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers
|
N/A | |
| Completed |
NCT01221207 -
Instant Total Contact Cast to Heal Diabetic Foot Ulcers
|
N/A | |
| Completed |
NCT01454401 -
LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
|
N/A | |
| Completed |
NCT01291160 -
Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers
|
Phase 2/Phase 3 | |
| Withdrawn |
NCT01105884 -
Clinical and Cost Effectiveness of Different Dressing Materials in Diabetic Foot Ulcers
|
N/A | |
| Completed |
NCT00536744 -
Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers
|
Phase 3 | |
| Terminated |
NCT00316537 -
Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers
|
Phase 1/Phase 2 | |
| Completed |
NCT00013299 -
Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3
|
Phase 2 | |
| Completed |
NCT00013286 -
A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk
|
Phase 2 | |
| Terminated |
NCT02667327 -
A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer
|
Phase 3 | |
| Not yet recruiting |
NCT00916292 -
Safety Study of Topical Human FGF-1 for Wound Healing
|
Phase 1 | |
| Completed |
NCT01154374 -
A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)
|
Phase 2 |