drugset / Trial / NCT01353937

Endogenous Progenitors Cell Therapy for Diabetic Foot Ulcers

NCT01353937

RandomizedParallel-groupSingle-blindTreatment

Summary

Diabetic foot ulcers, a complication of diabetes leading to 80.000 lower limb amputations annually in the US, are a significant burden to our health system, costing more than a billion dollars annually. Here, we propose a novel combination of two drugs (Mozobil® and Regranex®Gel) to mobilize a specific sub-type of stem cells (endothelial progenitor cells) from the bone marrow and traffic them toward the wound, increasing the blood supply that subsequently improves wound healing. Because we are using the human body's own resources to regenerate itself by targeting and correcting the underlying pathophysiology, we believe that this novel therapy yields great promise in the treatment of diabetic foot ulcers.

Timeline

Start
2014-04
Primary completion
2016-03
Completion
2016-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator AMD3100 Small molecule 240 ug/kg Subcutaneous
Comparator Becaplermin Protein / enzyme biologic Topical

Indications