NCT00351767
Completed
Phase 2
A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Effect of Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Diabetic Foot Ulcers
Overview
- Phase
- Phase 2
- Intervention
- telbermin
- Conditions
- Foot Ulcer, Diabetic
- Sponsor
- Genentech, Inc.
- Enrollment
- 170
- Primary Endpoint
- Skin re-epithelialization without drainage or dressing requirements
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
This is a Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of three different doses of topically applied telbermin in subjects ≥ 18 years old with diabetic foot ulcers. Approximately 160 adult subjects with Type 1 or Type 2 diabetes mellitus will be enrolled at approximately 40 investigational sites in the United States and Canada.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ability and willingness to comply with the following: study drug gel application and dressing changes as instructed; use offloading footwear and practice of rubbing prevention (shear injury) of the study ulcer for the duration of the study; adherence to study requirements or use of adequate caregiver assistance
- •For males and females of childbearing potential, use of an effective method of contraception
- •Type 1 or 2 diabetes mellitus
- •Inability to perceive 10 grams pressure in the peri-ulcer area using a Semmes-Weinstein 5.07 monofilament
- •At least one full thickness (i.e., extending into the subcutaneous tissue or beyond) ulcer of the foot at or below the malleolus that does not involve bone, tendons, ligaments, or muscle (University of Texas Classification System for Diabetic Foot Wounds, Stage 1a)
- •Estimated foot ulcer surface area, L x W, between ≥ 0.70 cm\^2 and ≤ 5.0 cm\^2 as measured at Treatment Day 1 Any subject who does not meet this criterion will not be eligible for randomization.
- •Eye examination (indirect ophthalmoscopy, fundus photography, or fluorescein angiography) within 6 months prior to randomization with no indication of proliferative diabetic retinopathy or wet age-related macular degeneration
Exclusion Criteria
- •Presence of an active systemic or local cancer or tumor of any kind (with the exception of non-melanoma skin cancer)
- •Proliferative diabetic retinopathy or wet age-related macular degeneration
- •A history of pulmonary edema
- •Active congestive heart failure
- •Active infection or cellulitis of any ulcer on the study foot
- •Active osteomyelitis of the study foot
- •Active connective tissue disease
- •Study ulcers with an etiology not related to diabetes (e.g., thermal, chemical, radiation insult)
- •History of active Charcot foot of the study foot within 6 months of screening
- •Treatment with systemic corticosteroids (equivalent to \> 10 mg/day of prednisone) or immunosuppressive or chemotherapeutic agents within 14 days prior to the first study drug gel application or likelihood to receive one of these therapies during study participation
Arms & Interventions
1
Intervention: telbermin
2
Intervention: telbermin
3
Intervention: telbermin
4
Intervention: placebo
Outcomes
Primary Outcomes
Skin re-epithelialization without drainage or dressing requirements
Time Frame: 12 weeks
Secondary Outcomes
- Complete closure of the study ulcer(24 weeks)
- Durability of closure(Time to recurrence)
- Change and percent change in ulcer surface area(12 and 24 weeks)
- Number of debridements performed(12 weeks)
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