Efficacy of R-Pdf/Gbb in Healing Wounds Caused by Third Degree Thermal and Electrical Burns
Recruitment status was: Not yet recruiting
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.|
- Complete healing of the third degree burn wound. [ Time Frame: 3 months. ] [ Designated as safety issue: Yes ]
- Improvement in general condition of the study subjects without any complications. [ Time Frame: 3 months. ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||April 2012|
|Estimated Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Drug: R-Pdf/Gbb 0.01% gel
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812513
|United States, New Jersey|
|Saint. Barnabas Medical Center, The Burn Center|
|Livingston, New Jersey, United States, 07039|
|Study Chair:||Ratna Grewal, MD||American Scitech International- eCRO|
|Principal Investigator:||Nani E Mansour, MD||Saint Barnabas Medical Center, The Burn Center|