Evaluation of ABSOLVE in Diabetic Foot Ulcers (ABSOLVE)
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|ClinicalTrials.gov Identifier: NCT03037970|
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : January 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcers||Drug: RhPDGF-BB Other: Placebo||Phase 2|
Patients with diabetes are at risk for developing serious health problems that may affect the feet, eyes, kidneys, skin and heart. Foot ulcerations are of great significance to the lives of millions of diabetic patients, representing one of the most common and serious complications in these patients. Up to 25% of diabetics will develop a diabetic foot ulcer (DFU) at some point in their lifetime. The prevalence of DFUs among diabetics is 4% to 10%. More than half of all foot ulcers will become infected requiring hospitalization and 1 in 5 will require amputation. Foot ulcers account for 85,000 non-trauma related lower limb amputations annually in the USA. Every 20 seconds, somewhere in the world, a limb is lost as a consequence of diabetes. Moreover, 85% of leg amputations are preceded by DFUs and more than 60% of non-traumatic lower extremity amputations (LEA) performed in the United States each year occurs secondary to complications of diabetes mellitus. After a major amputation, 50% of patients will have another limb amputated within two years. Mortality rates subsequent to amputation are alarmingly high - up to 40% at 1 year and 80% at 5 years. Patients with a history of a DFU have a 40% greater mortality rate compared to patients with diabetes alone. Improved treatments for DFUs are clearly a matter of great significance.
In this study, the investigation will be focused on the safety and efficacy of ABSOLVE in treating diabetic foot ulcers.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a randomized, blinded, two-arm, clinical study|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||One component of the study drug will be blinded as the study employs a placebo-controlled arm. More specifically, vials containing rhPDGF or saline will be the same Type I, sodium borosilicate vials with rubber stopper, and plastic cap. Each vial will contain 3 ml of clear liquid. The vials will have blinded labels. Type I collagen wound dressings, on the other hand, will all be the same and are not part of the blinding.|
|Official Title:||A Prospective Randomized Controlled Blinded Study to Evaluate the Safety and Efficacy of rhPDGF-BB Saturated Collagen Wound Dressings on Diabetic Foot Ulcers|
|Estimated Study Start Date :||January 30, 2017|
|Estimated Primary Completion Date :||August 15, 2017|
|Estimated Study Completion Date :||October 15, 2017|
Type I collagen sheet soaked in a solution containing rhPDGF-BB.
One 2x4x.3cm of collagen wound matrix is saturated with 2.0 ml of the rhPDGF-BB solution.
Other Name: ABSOLVE
Placebo Comparator: Placebo
Collagen sheet soaked with saline solution.
Collagen Wound Dressing wetted with buffer.
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Week 0 - 24 ]Determine safety and tolerability of ABSOLVE on patients having a poorly healing diabetic foot ulcer.
- Successful wound healing for at least two consecutive measurements. (Efficacy) [ Time Frame: Week 12 ]Successfully healed wound must remain closed for at least two consecutive measurements, one of which will be at the 12-week examination.
- Wound Size [ Time Frame: Week 0 - 24 ]The percent change in wound size (closure) over time.
- Wound Closure [ Time Frame: Week 0 - 24 ]Percent incidence of complete wound closure over time.
- Complication rate [ Time Frame: Week 0 - 24 ]Reduction in complications.
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): NCT03037970
|Contact: Sam Lynch, DMSc, DMDfirstname.lastname@example.org|
|Contact: Damon Michaelsemail@example.com|
|Centro Medico Militar||Recruiting|
|Guatemala City, Guatemala, 010116|
|Principal Investigator:||Luis Gonzalez, MD||Centro Medico Militar, Guatemala|