Efficacy of R-Pdf/Gbb in Healing Wounds Caused by Third Degree Thermal and Electrical Burns
Recruitment status was Not yet recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Burns Electric Burns |
Drug: R-Pdf/Gbb 0.01% gel |
Phase 2 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 120 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 rgreywal@americanscitech.com | |
| Contact: Ratna Grewal, MD 908-941-5480 rgreywal@americanscitech.com | |
| Study Chair: | Ratna Grewal, MD | American Scitech International- eCRO | |
| Principal Investigator: | Nani E Mansour, MD | Saint Barnabas Medical Center, The Burn Center |
More Information
No publications provided
| Responsible Party: | Dr. R. Grewal, American Scitech International |
| ClinicalTrials.gov Identifier: | NCT00812513 History of Changes |
| Other Study ID Numbers: | ASI-TEBII1208 |
| Study First Received: | December 19, 2008 |
| Last Updated: | July 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by American Scitech International:
|
rhPDGF-BB Platelet derived growth factor Burns Thermal burns Electric burns |
Additional relevant MeSH terms:
|
Burns Wounds and Injuries Mitogens Platelet-derived growth factor BB Angiogenesis Inducing Agents Angiogenesis Modulating Agents |
Growth Substances Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 02, 2015