A Study to Assess the Effect of Topical Recombinant Human Vascular Endothelial Growth Factor for Induction of Healing of Diabetic Foot Ulcers

NCT00351767 | Completed Phase 2

• 1 other identifier: VGF3554g
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Foot Ulcer, Diabetic

Keywords

Diabetes; Dabetic Feet

Outcome Measures

Primary Outcomes (1)

• Skin re-epithelialization without drainage or dressing requirements

  12 weeks

Secondary Outcomes (4)

• 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

Study Arms (4)

1

EXPERIMENTAL

Drug: telbermin

2

EXPERIMENTAL

Drug: telbermin

3

EXPERIMENTAL

Drug: telbermin

4

PLACEBO COMPARATOR

Drug: placebo

Interventions

placebo DRUG

Topically applied

4

telbermin DRUG

Topically applied

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Previous or current radiation therapy to the distal lower extremity or likelihood to receive this therapy during study participation
• Pregnancy or lactation
• Presence of more than two full-thickness ulcers on the study foot
• End-stage renal failure necessitating chronic hemodialysis or chronic ambulatory peritoneal dialysis
• Poor nutritional status

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Pual Kwon, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2006
• First Posted: July 13, 2006
• Study Start: January 1, 2006
• Primary Completion: January 1, 2008
• Last Updated: January 25, 2013

Record last verified: 2013-01