Efficacy of R-Pdf/Gbb in Healing Wounds Caused by Third Degree Thermal and Electrical Burns

Study Description

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Brief Summary:

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 (R-Pdf/Gbb) 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 R-Pdf/Gbb 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 or disease	Intervention/treatment	Phase
Burns; Electric Burns	Drug: R-Pdf/Gbb 0.01% gel	Phase 2

Detailed Description:

The R-Pdf/Gbb 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 R-Pdf/Gbb gel in treating wounds caused by III degree thermal and electrical burns.

HYPOTHESIS 1: That the applications of R-Pdf/Gbb 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 R-Pdf/Gbb 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 R-Pdf/Gbb 0.01% gel applied once daily.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	120 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II Study of Efficacy of Recombinant Human Platelet-derived Growth Factor (R-Pdf/Gbb) in Healing Wounds Caused by Third Degree Thermal and Electrical Burns.
Study Start Date :	July 2011
Estimated Primary Completion Date :	April 2012
Estimated Study Completion Date :	April 2012

Arms and Interventions

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Intervention Details:

Drug: R-Pdf/Gbb 0.01% gel
rhPDGF 0.01% gel is applied to the wound, then covered with dressing once daily for 3 months
Other Name: Recombinant human platelet-derived growth factor

Outcome Measures

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Primary Outcome Measures :

1. Complete healing of the third degree burn wound. [ Time Frame: 3 months. ]

Secondary Outcome Measures :

1. Improvement in general condition of the study subjects without any complications. [ Time Frame: 3 months. ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

United States, New Jersey
Saint. Barnabas Medical Center, The Burn Center	Not yet recruiting
Livingston, New Jersey, United States, 07039
Contact: Nani E Mansour, MD 908-941-5480 rgreywal@americanscitech.com
Contact: Ratna Grewal, MD 908-941-5480 rgreywal@americanscitech.com

Sponsors and Collaborators

American Scitech International

Johnson & Johnson

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr. R. Grewal, American Scitech International
ClinicalTrials.gov Identifier:	NCT00812513 History of Changes
Other Study ID Numbers:	ASI-TEBII1208
First Posted:	December 22, 2008
Last Update Posted:	July 20, 2011
Last Verified:	July 2011

Keywords provided by American Scitech International:

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

Additional relevant MeSH terms:

Burns; Burns, Electric; Wounds and Injuries; Electric Injuries; Mitogens; Becaplermin	Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Angiogenesis Inducing Agents; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs