A Study Evaluating Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

rhuMAb VEGF (telbermin)

About this trial

This is an interventional treatment trial for Foot Ulcer focused on measuring Diabetes, Diabetic, Diabetic Foot Ulcer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed Informed Consent 18-80 years old For females of childbearing potential, use of an effective method of contraception: abstinence; surgical sterilization; oral contraceptives; barrier contraception with either a condom, sponge, or diaphragm in conjunction with spermicidal gel; an intrauterine device (IUD); or contraceptive hormone implant or patch Type 1 or 2 diabetes mellitus Single, full-thickness (i.e., extending into the subcutaneous tissue or beyond) ulcer of the foot below the malleolus that does not involve bone, tendons, ligaments, or muscle Chronic ulcer with a duration of ≥ 4 weeks but < 6 months Ulcer area with sharp debridement of ≥ 1.0 cm^2 and ≤ 4.0 cm^2 Ankle-brachial index (ABI) of ≥ 0.6 and ≤ 1.2 on the study foot Glycosylated hemoglobin A1c (HbA1c) of ≤ 12% 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 Ulcers with an etiology not related to diabetes (e.g., thermal, chemical, radiation insult) Connective tissue disease Active osteomyelitis of the study foot Subjects with ulcers related to an incompletely healed amputation wound Subjects with Charcot or other deformity of the study foot involving the study ulcer Immunosuppressive treatment, including radiation therapy, non-inhaled corticosteroids (inhaled corticosteroid ≤ 1000 ug daily dose is acceptable), and chemotherapy Pregnancy or lactation Multiple ulcers in the study foot Renal failure (serum creatinine of >3.0 mg/dL) Poor nutritional status (albumin of <3.0 g/dL) Known hypersensitivity to any ingredients of telbermin, placebo, or vehicle, including excipients in the formulation of telbermin or placebo gel (trehalose dihydrate, polysorbate 20, succinic acetic acid, succinic acetic acid disodium, and hexahydrate) Known prior inability to complete required study visits during treatment period Use of any other investigational drug or therapy on the study foot within the past month Previous use of a platelet-derived or other growth factors on the study ulcer within the past 3 months

Sites / Locations

Outcomes

Primary Outcome Measures

Incidence of clinically significant hypotension.

Secondary Outcome Measures

Incidence of clinically significant ulcer infection defined by increased discharge and malodorous exudates from the ulcer, fever, and a white blood cell (WBC) count of >10,000/uL

Development of anti telbermin antibodies

Incidence of adverse events

Percent reduction in total ulcer surface area.

Full Information

NCT ID

NCT00069446

First Posted

September 25, 2003

Last Updated

May 9, 2017

Sponsor

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00069446

Brief Title

A Study Evaluating Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

August 2003 (Actual)

Primary Completion Date

October 2004 (Actual)

Study Completion Date

October 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Genentech, Inc.

4. Oversight

5. Study Description

Brief Summary

This is a Phase I, double blind, randomized, placebo-controlled study that will enroll approximately 50 adult subjects with Type 1 or Type 2 diabetes mellitus and chronic, diabetic foot ulcers. The study will be conducted at approximately 12 investigational sites in the United States.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Foot Ulcer

Keywords

Diabetes, Diabetic, Diabetic Foot Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Enrollment

50 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

rhuMAb VEGF (telbermin)

Primary Outcome Measure Information:

Title

Incidence of clinically significant hypotension.

Secondary Outcome Measure Information:

Title

Incidence of clinically significant ulcer infection defined by increased discharge and malodorous exudates from the ulcer, fever, and a white blood cell (WBC) count of >10,000/uL

Title

Development of anti telbermin antibodies

Title

Incidence of adverse events

Title

Percent reduction in total ulcer surface area.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Signed Informed Consent 18-80 years old For females of childbearing potential, use of an effective method of contraception: abstinence; surgical sterilization; oral contraceptives; barrier contraception with either a condom, sponge, or diaphragm in conjunction with spermicidal gel; an intrauterine device (IUD); or contraceptive hormone implant or patch Type 1 or 2 diabetes mellitus Single, full-thickness (i.e., extending into the subcutaneous tissue or beyond) ulcer of the foot below the malleolus that does not involve bone, tendons, ligaments, or muscle Chronic ulcer with a duration of ≥ 4 weeks but < 6 months Ulcer area with sharp debridement of ≥ 1.0 cm^2 and ≤ 4.0 cm^2 Ankle-brachial index (ABI) of ≥ 0.6 and ≤ 1.2 on the study foot Glycosylated hemoglobin A1c (HbA1c) of ≤ 12% 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 Ulcers with an etiology not related to diabetes (e.g., thermal, chemical, radiation insult) Connective tissue disease Active osteomyelitis of the study foot Subjects with ulcers related to an incompletely healed amputation wound Subjects with Charcot or other deformity of the study foot involving the study ulcer Immunosuppressive treatment, including radiation therapy, non-inhaled corticosteroids (inhaled corticosteroid ≤ 1000 ug daily dose is acceptable), and chemotherapy Pregnancy or lactation Multiple ulcers in the study foot Renal failure (serum creatinine of >3.0 mg/dL) Poor nutritional status (albumin of <3.0 g/dL) Known hypersensitivity to any ingredients of telbermin, placebo, or vehicle, including excipients in the formulation of telbermin or placebo gel (trehalose dihydrate, polysorbate 20, succinic acetic acid, succinic acetic acid disodium, and hexahydrate) Known prior inability to complete required study visits during treatment period Use of any other investigational drug or therapy on the study foot within the past month Previous use of a platelet-derived or other growth factors on the study ulcer within the past 3 months

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tim Breen, Ph.D.

Organizational Affiliation

Genentech, Inc.

Official's Role

Study Director

Foot Ulcer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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