BurnsPhase 2NCT00812513
Efficacy of R-Pdf/Gbb in Healing Wounds Caused by Third Degree Thermal and Electrical Burns
A Phase 2 study testing R-Pdf/Gbb 0.01% gel in people with Burns and Electric Burns, run by American Scitech International at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Burns, Electric Burns
- What is being tested?
- R-Pdf/Gbb 0.01% gel
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Apr 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint. Barnabas Medical Center, The Burn Center
Livingston, New Jersey, 07039
Nani E Mansour, MD, 908-941-5480, rgreywal@americanscitech.com
Ratna Grewal, MD, 908-941-5480, rgreywal@americanscitech.com
About this study
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.
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.
Read the 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.
- Conditions
- Burns, Electric Burns
- Being tested
- R-Pdf/Gbb 0.01% gel
- Keywords
- rhPDGF-BB, Platelet derived growth factor, Burns, Thermal burns, Electric burns
- Medical subject headings
- Burns, Burns, Electric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-Pdf/Gbb 0.01% gelDrug
Also called Recombinant human platelet-derived growth factor
rhPDGF 0.01% gel is applied to the wound, then covered with dressing once daily for 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete healing of the third degree burn wound.
Measured: 3 months.
Secondary outcomes (1)
Improvement in general condition of the study subjects without any complications.
Measured: 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startJul 2011
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Scitech International
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Investigators
- Ratna Grewal, MD, Study chair, American Scitech International- eCRONani E Mansour, MD, Principal investigator, Saint Barnabas Medical Center, The Burn Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812513
- Sponsor's protocol ID
- ASI-TEBII1208
- Status last verified
- Jul 2011
- First submitted
- 19 Dec 2008
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00812513
- Acronym / sponsor ID
- ASI-TEBII1208
- Conditions
- Burns, Electric Burns
- Keywords
- rhPDGF-BB, Platelet derived growth factor, Burns, Thermal burns, Electric burns
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- American Scitech InternationalUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Jul 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 22 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-Pdf/Gbb 0.01% gelAlso: Recombinant human platelet-derived growth factorrhPDGF 0.01% gel is applied to the wound, then covered with dressing once daily for 3 months | Drug | – |
Primary outcome
Complete healing of the third degree burn wound.
Time frame: 3 months.
1 secondary outcome
Improvement in general condition of the study subjects without any complications.
Time frame: 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
Related trials for Burns
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saint. Barnabas Medical Center, The Burn Center
Livingston, United States
Ratna Grewal, MD study chair
American Scitech International- eCRO
Nani E Mansour, MD principal investigator
Saint Barnabas Medical Center, The Burn Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R-Pdf/Gbb 0.01% gel in people with Burns and Electric Burns, run by American Scitech International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete healing of the third degree burn wound. (time frame: 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2011.