Endogenous Progenitors Cell Therapy for Diabetic Foot Ulcers

Withdrawn before enrolling · Phase 1

Conditions studied: Diabetic Ulcer

In brief

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.

Key facts

Study ID

NCT01353937

Run by

NYU Langone Health

People needed

0

Starts

2014-04-01

Expected to finish

2016-09-01

Last updated by the study team

2016-03-04

Who can join

Age: 35 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Insulin-dependant type 2 diabetic patients
• Age between 35 and 60 years-old
• HbA1C between 6 and 12%
• Full-thickness diabetic neuropathic foot ulcers
• ≥ 2 weeks duration
• Following standard of care débridement, ulcer size must be between 1 and 6 cm2
• Adequate perfusion, defined as either transcutaneous oxygen measurements on the dorsum of the foot >30 mmHg or ankle brachial indexes 0.7<ABI<1.2, as well as toe pressure >30 mmHg.

You may not qualify if…

• Clinical infection at the studied ulcer site (bacterial and fungal)
• Clinically significant lower-extremity ischemia (as defined by an ankle/brachial index of <0.65)
• Active Charcot's foot as determined by clinical and radiographic examination
• Ulcer of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis-related ulcers, and especially venous stasis ulcer)
• Significant medical conditions that would impair wound healing will also be excluded from the study. These conditions include liver disease, aplastic anemia, scleroderma and malignancy, treatment with immunosuppressive agents or steroids, myocardial infarcts, stroke, major surgery within 6 months of the study, usage of tobacco
• Subjects with cancerous or pre-cancerous lesions in the area to be treated
• Body weight > 160 kg (because of Plerixafor's pharmacokinetic limitation)
• Severe renal dysfunction (creatinine clearance < 50 ml/min)
• Severe non-proliferative or proliferative diabetic retinopathy
• Capillary blood glucose >350

Where it is running

• Helen L. & Martin S. Kimmel Wound Healing Center at the NYU Hospital for Joint Diseases — New York, New York, United States

Full record on ClinicalTrials.gov

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