Diabetic Foot Ulcers Clinical Trial
Official title:
Phase 1/2, Multi-Dose, Evaluator-Blinded, Randomized, Vehicle & Standard Of Care-Controlled Dose-Escalation Study To Assess Safety, Tolerability, Pharmacokinetics Of Topical Selinexor In Patients With Diabetic Foot Ulcers
Patients with eligible diabetic foot ulcers will be screened, treated, and followed for complete ulcer closure. This is a randomized trial. All patients will receive standard-of-care treatment. Additionally, some patients will receive treatment with topical Selinexor gel and some will receive topical placebo gel.
Approximately 30 patients who meet the eligibility criteria will be enrolled. Eligible patients with diabetic foot ulcers will be screened, randomized, treated, and followed for complete ulcer closure. After screening, qualified patients will be treated for up to 12 weeks. Patients who achieve complete ulcer closure will be followed for an additional 12 weeks. All patients will receive standard-of-care treatment. After randomization some patients will be treated with topical Selinexor gel twice weekly and some patients will be treated with a topical placebo gel twice weekly. Patients receiving Selinexor will be assigned to a sequential treatment cohort, either a 10 μM (μmol/L), 30 μM, or 70 μM dose. ;
| 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 | |
| Terminated |
NCT01816633 -
Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers
|
N/A | |
| Completed |
NCT02222376 -
Effect of Topic Pirfenidone in Diabetic Ulcers
|
Phase 3 | |
| Completed |
NCT01454401 -
LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
|
N/A | |
| Completed |
NCT01221207 -
Instant Total Contact Cast to Heal Diabetic Foot Ulcers
|
N/A | |
| Withdrawn |
NCT01105884 -
Clinical and Cost Effectiveness of Different Dressing Materials in Diabetic Foot Ulcers
|
N/A | |
| Completed |
NCT01291160 -
Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers
|
Phase 2/Phase 3 | |
| 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 |