Efficacy of R-Pdf/Gbb in Healing Wounds Caused by Third Degree Thermal and Electrical Burns
Information source: American Scitech International
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Burns; Electric Burns
Intervention: R-Pdf/Gbb 0.01% gel (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: American Scitech International
Official(s) and/or principal investigator(s):
Ratna Grewal, MD, Study Chair, Affiliation: American Scitech International- eCRO
Nani E Mansour, MD, Principal Investigator, Affiliation: Saint Barnabas Medical Center, The Burn Center
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
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
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
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 design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Complete healing of the third degree burn wound.
Secondary outcome: Improvement in general condition of the study subjects without any complications.
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
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.
Minimum age: 18 Years.
Maximum age: 75 Years.
- 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.
- 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)
Locations and Contacts
Saint. Barnabas Medical Center, The Burn Center, Livingston, New Jersey 07039, United States; Not yet recruiting
Nani E Mansour, MD, Phone: 908-941-5480, Email: email@example.com
Ratna Grewal, MD, Phone: 908-941-5480, Email: firstname.lastname@example.org
Starting date: July 2011
Last updated: July 19, 2011