Diabetic Foot Ulcers Clinical Trial
Official title:
A Clinical Study Using Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
This study is to evaluate the efficacy of OCM™ used in combination with off-loading devices for the treatment of diabetic foot ulcers.
The study will include three phases: screening phase, treatment phase and healing confirmation. All measurements in the trial are captured by Tissue Analytics.The two week screening phase is to confirm the chronicity of the diabetic foot ulcer (DFU) and the eligibility of subjects. Subjects will be treated with standard of care (SOC) which includes cleaning of the wound, debridement when needed, dressing, and offloading. If the ulcer decreases by 30% in area measurement after 2 weeks of SOC, then the subject does not qualify for the treatment phase. The treatment phase begins with assessment to confirm continued eligibility and if met, subjects are treated weekly with the OCM™ therapy plus continued offloading. At the conclusion of 4 weekly treatments, the ulcer will be assessed by PI for response and evaluation of percent area reduction. Continued therapy through treatment visit 12 is at the PI's discretion where percent area reduction is assessed and recorded. OCM™ results will be compared to a Control Group of subjects identified and matched retrospectively from the same site, who received the same advanced treatments that the OCM™ treated cohort had received prior to the trial. ;
| 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 |
NCT02631512 -
Evaluation of Woulgan in Diabetic Foot Ulcer
|
Phase 4 | |
| Terminated |
NCT01816633 -
Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers
|
N/A | |
| Completed |
NCT02222376 -
Effect of Topic Pirfenidone in Diabetic Ulcers
|
Phase 3 | |
| 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 | |
| Not yet recruiting |
NCT02672280 -
Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects
|
Phase 1/Phase 2 |