Endogenous Progenitors Cell Therapy for Diabetic Foot Ulcers

NCT01353937 | Withdrawn Phase 1 DMC

• 1 other identifier: 10-02116
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Ulcer

Keywords

wound healing

Outcome Measures

Primary Outcomes (2)

• Rate of Wound Closure

  The safety and efficacy of AMD3100 (Plerixafor) with rhPDGF-BB (Becaplermin) compared to two historical treatments group (Beclapermin versus standard of care (SOC) treatment) for the treatment of DFUs.\[21\] The central hypothesis to be tested is that a novel combination therapy will significantly increase the rate of closure of DFUs as compared to historical treatments groups, while presenting no major side effect.

  1 year

• Quality of Life

  Test whether patients treated with the novel combination therapy will have an improvement in their quality of life, with higher scores on the DFS-SF than those of the historical control groups.

  4 weeks

Secondary Outcomes (11)

• Glycosylated hemoglobin (HbA1C)

  4 weeks

• capillary blood glucose (ACCUCHEK Finger Stick)

  4 weeks

• Transcutaneous oxygen tension measurements on wound and 1 cm-radius periphery (Radiometer adult sensor)

  4 weeks

• Ankle-brachial index (ABI, Prestige sphygmomanometer and Summit doppler probe)

  4 weeks

• pain (Visual-Analog Scale)

  4 weeks

Study Arms (3)

Standard of Care

NO INTERVENTION

All patients will be receiving the Standard of Care treatments regardless of whether or not they are receiving study drug.

Novel Combination Therapy

ACTIVE COMPARATOR

AMD3100 (Plerixafor) injection with Regranex Gel topical application

Drug: AMD3100 injection + rhPDGF-BB topical

Becaplermin (Regranex Gel)

ACTIVE COMPARATOR

Topical application

Drug: AMD3100 injection + rhPDGF-BB topical

Interventions

AMD3100 injection + rhPDGF-BB topical DRUG

drug therapy to be given for the first 2 week duration given on a daily basis initiated during the first visit (Day 0).

Also known as: AMD3100 (Plerixafor), rhPDGF-BB (Becaplermin), Regranex Gel

Becaplermin (Regranex Gel); Novel Combination Therapy

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institutes of Health (NIH): collaborator
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Helen L. & Martin S. Kimmel Wound Healing Center at the NYU Hospital for Joint Diseases

New York, New York, 10003, United States

Location

MeSH Terms

Interventions

plerixafor; Becaplermin

Intervention Hierarchy (Ancestors)

Proto-Oncogene Proteins c-sis; Platelet-Derived Growth Factor; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; DNA-Binding Proteins; Proteins; Biological Factors

Study Officials

• Stephen Warren, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2011
• First Posted: May 16, 2011
• Study Start: April 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 4, 2016

Record last verified: 2016-03

Locations

US (1)