Efficacy of rhPDGF-BB in Healing Wounds Caused by Third Degree Thermal and Electrical Burns - Full Text View

Sponsors and Collaborators:	American Scitech International Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	American Scitech International
ClinicalTrials.gov Identifier:	NCT00812513

Purpose

Platelet Derived Growth Factor (PDGF) is a potent mitogen for a wide range of cell types including fibroblasts, smooth muscle and connective tissue. Recombinant human platelet derived growth factor (rhPDGF-BB) has biologic activity similar to endogenous platelet derived growth factor (PDGF). Biologic activity of PDGF includes encouraging chemotaxis and proliferation of cells responsible for wound repair and it augments production of granulation tissue.

The growth factor rhPDGF is found effective in patients having diabetic foot ulcer grade III and IV. The nature of wounds in the third degree burns is similar so far as healing process is concerned.

The purpose of this study is to test the hypotheses that the application of rhPDGF-BB 0.01% gel on the third degree thermal and electrical burns will heal these wounds within 3 months and there will be improvement in general condition of the patients without any complications.

Condition	Intervention	Phase
Burns Electric Burns	Drug: rhPDGF 0.01% gel	Phase II

MedlinePlus related topics: Burns

Drug Information available for: Becaplermin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase II Study of Efficacy of Recombinant Human Platelet-Derived Growth Factor (rhPDGF-BB) in Healing Wounds Caused by Third Degree Thermal and Electrical Burns.

Further study details as provided by American Scitech International:

Primary Outcome Measures:

Complete healing of the third degree burn wound. [ Time Frame: 3 months. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Improvement in general condition of the study subjects without any complications. [ Time Frame: 3 months. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	June 2009
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Intervention Details:

rhPDGF 0.01% gel is applied to the wound, then covered with dressing once daily for 3 months

Detailed Description:

The rhPDGF-BB is recombinant human platelet-derived growth factor. It has been demonstrated that rhPDGF is effective in enhancing wound healing.

OBJECTIVE: The primary objective of the study is to determine the efficacy of rhPDGF-BB gel in treating wounds caused by III degree thermal and electrical burns.

HYPOTHESIS 1: That the applications of rhPDGF-BB 0.01% gel on III degree thermal and electrical burns will heal these wounds within 3 months.

HYPOTHESIS 2: Subjects, who having III degree thermal and electrical burns with the treatment of rhPDGF-BB 0.01% gel, will show improvement in general condition without any complications.

We aim to test these hypotheses by evaluating the clinical outcome in about 120 patients after three months of treatment with rhPDGF-BB 0.01% gel applied once daily.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients willing to sign Informed consent.
Patients of both genders.
Patients between ages of 18 to 75 years.
Patients having third degree wounds caused by thermal and electrical burns.
Patients not willing to undergo skin grafting.
Patients with multiple wounds are considered but each burn wound surface area will be less than 1-8 cm2.
Wounds with adequate perfusion as assessed with the help of laser Doppler flowmeter.

Exclusion Criteria:

Patient refuses to sign informed consent.
Burnt wounds severity less/more than III degree (i.e. I, II, IV degree burns).
Patients having known neoplasm at the site of application.
Patients with low serum proteins.
Patients with uncontrolled hyperglycemia.
Patients who are taking Ibuprofen.
Patients with known hypersensitivity to parabens.
All other burns except thermal and electrical burns.
Neurological or psychiatric pathologies.
Women who are pregnant or nursing and women of child bearing age, who are not taking contraceptives or not willing to use them for the period of treatment.
Local or systemic infection
Conditions that would interfere with wound healing (diabetes, hypertension, inflammatory diseases treated by corticoids)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812513

Locations

United States, New Jersey
Saint. Barnabas Medical Center, The Burn Center
Livingston, New Jersey, United States, 07039

Sponsors and Collaborators

American Scitech International

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Chair:	Ratna Grewal, MD	American Scitech International- eCRO
Principal Investigator:	Nani E Mansour, MD	Saint Barnabas Medical Center, The Burn Center

More Information

Responsible Party:	American Scitech International ( Dr. R. Grewal )
Study ID Numbers:	ASI-TEB7101
Study First Received:	December 19, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00812513
Health Authority:	United States: Institutional Review Board

Keywords provided by American Scitech International:

rhPDGF-BB
Platelet derived growth factor
Burns
Thermal burns
Electric burns

Study placed in the following topic categories:

Burns, Electric
Burns
Platelet-derived growth factor BB
Wounds and Injuries
Disorders of Environmental Origin

Additional relevant MeSH terms:

Electric Injuries
Growth Substances
Physiological Effects of Drugs

Angiogenesis Inducing Agents
Angiogenesis Modulating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009