Efficacy of R-Pdf/Gbb in Healing Wounds Caused by Third Degree Thermal and Electrical Burns
|ClinicalTrials.gov Identifier: NCT00812513|
Recruitment Status : Unknown
Verified July 2011 by American Scitech International.
Recruitment status was: Not yet recruiting
First Posted : December 22, 2008
Last Update Posted : July 20, 2011
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Drug: R-Pdf/Gbb 0.01% gel
- Complete healing of the third degree burn wound. [ Time Frame: 3 months. ]
- Improvement in general condition of the study subjects without any complications. [ Time Frame: 3 months. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812513
|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 email@example.com|
|Contact: Ratna Grewal, MD 908-941-5480 firstname.lastname@example.org|
|Study Chair:||Ratna Grewal, MD||American Scitech International- eCRO|
|Principal Investigator:||Nani E Mansour, MD||Saint Barnabas Medical Center, The Burn Center|