Common Foot Problems |
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Clinical Trial: RhVEGF (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers
This study is no longer recruiting patients.
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Purpose
The purpose of this study is to assess the safety of telbermin applied topically to chronic, diabetic foot ulcers and to explore the possible effectiveness of this treatment to induce healing of diabetic foot ulcers.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Diabetic Foot | Drug: rhVEGF (telbermin) | Phase I |
MedlinePlus related topics: Diabetic Foot
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: An Exploratory, Double-blind, Randomized, Placebo-controlled Study Evaluating Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers
Eligibility
Ages Eligible for Study: 18 Years - 80 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Type 1 or 2 diabetes mellitus.
- Single, full-thickness (i.e. extending into the subcutaneous tissue or beyond) ulcer of the foot that does not involve bone, tendons, ligaments, or muscle below the malleolus.
- Chronic ulcer with a duration of >4 weeks but <6 months.
Exclusion Criteria:
- History of neoplasia or current neoplasia (with the exception of non-melanoma skin cancer).
- Proliferative diabetic retinopathy or wet age-related macular degeneration.
- Active ulcer infection or cellulitis of any ulcer.
- Immunosuppressive treatment, including radiation therapy, corticosteroids, and chemotherapy.
- Pregnancy or lactation.
- Multiple ulcers in the study foot.
- Known prior inability to complete required study visits during treatment period.
- Current use of any other investigational drug.
- Previous use of a platelet-derived or other growth factors on the study ulcer within the past 3 months.
Location Information
Colorado
Trial Information Support Center, Denver, Colorado, United States
More Information
Record last reviewed: December 2004
Last Updated: December 16, 2004
Record first received: September 25, 2003
ClinicalTrials.gov Identifier: NCT00069446
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Common Foot Problems (Cleveland Clinic)
- Foot Problems (Cleveland Clinic)

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