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

NCT00812513 | Unknown Phase 2

• 1 other identifier: ASI-TEBII1208
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Electric Burns

Keywords

rhPDGF-BB; Platelet derived growth factor; Burns; Thermal burns; Electric burns

Outcome Measures

Primary Outcomes (1)

• Complete healing of the third degree burn wound.

  3 months.

Secondary Outcomes (1)

• Improvement in general condition of the study subjects without any complications.

  3 months.

Interventions

R-Pdf/Gbb 0.01% gel DRUG

rhPDGF 0.01% gel is applied to the wound, then covered with dressing once daily for 3 months

Also known as: Recombinant human platelet-derived growth factor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• American Scitech International: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Saint. Barnabas Medical Center, The Burn Center

Livingston, New Jersey, 07039, United States

Location

MeSH Terms

Conditions

Burns; Burns, Electric

Interventions

Gels; Genes, sis

Condition Hierarchy (Ancestors)

Wounds and Injuries; Electric Injuries

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Proto-Oncogenes; Oncogenes; Genes, Neoplasm; Genes; Genome Components; Genome; Genetic Structures; Genetic Phenomena

Study Officials

• Ratna Grewal, MD

  American Scitech International- eCRO

  STUDY CHAIR

• Nani E Mansour, MD

  Saint Barnabas Medical Center, The Burn Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 22, 2008
• Study Start: July 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 20, 2011

Record last verified: 2011-07

Locations

US (1)