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

Burns Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00812513
• Other study ID #: ASI-TEBII1208
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 19, 2008
• Last updated: July 19, 2011
• Start date: July 2011
• Est. completion date: April 2012

Study information

• Verified date: July 2011
• Source: American Scitech International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Electric Burns

Intervention

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

Locations

Country	Name	City	State
United States	Saint. Barnabas Medical Center, The Burn Center	Livingston	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
American Scitech International	Johnson & Johnson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete healing of the third degree burn wound.		3 months.	Yes
Secondary	Improvement in general condition of the study subjects without any complications.		3 months.	Yes