Expired Study
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Livingston, New Jersey 07039


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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

ASI-TEBII1208


NCT ID:

NCT00812513


Secondary ID:


Study Acronym:


Brief Title:

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


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.


Overall Status:

Not yet recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

American Scitech International


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Interven


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

120


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Ratna Grewal, MD
Study Chair
American Scitech International- eCRO

Study Dates

Start Date:July 2011
Completion Date:April 2012
Completion Type:Anticipated
Primary Completion Date:April 2012
Primary Completion Type:Anticipated
Verification Date:July 2011
Last Changed Date:July 19, 2011
First Received Date:December 19, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Improvement in general condition of the study subjects without any complications.
Time Frame:3 months.
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Complete healing of the third degree burn wound.
Time Frame:3 months.
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:R-Pdf/Gbb 0.01% gel
Description:rhPDGF 0.01% gel is applied to the wound, then covered with dressing once daily for 3 months
Other Name:Recombinant human platelet-derived growth factor

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:American Scitech International
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Johnson & Johnson

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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