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

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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
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by:
American Scitech International

Study Description
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Brief Summary:

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

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : July 2011
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Becaplermin

Arms and Interventions
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Intervention Details:
  • Drug: R-Pdf/Gbb 0.01% gel
    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

Outcome Measures
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Primary Outcome Measures :
  1. Complete healing of the third degree burn wound. [ Time Frame: 3 months. ]

Secondary Outcome Measures :
  1. Improvement in general condition of the study subjects without any complications. [ Time Frame: 3 months. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812513


Locations
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   
Sponsors and Collaborators
American Scitech International
Johnson & Johnson
Investigators
Study Chair: Ratna Grewal, MD American Scitech International- eCRO
Principal Investigator: Nani E Mansour, MD Saint Barnabas Medical Center, The Burn Center
More Information
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Responsible Party: Dr. R. Grewal, American Scitech International
ClinicalTrials.gov Identifier: NCT00812513     History of Changes
Other Study ID Numbers: ASI-TEBII1208
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 2011

Keywords provided by American Scitech International:
rhPDGF-BB
Platelet derived growth factor
Burns
Thermal burns
Electric burns

Additional relevant MeSH terms:
Burns
Burns, Electric
Wounds and Injuries
Electric Injuries
Mitogens
Becaplermin
 Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inducing Agents
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs