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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
Sponsor:
Collaborators:
Medelis Inc.
Centro Medico Militar
Information provided by (Responsible Party):
Lynch Biologics LLC

Brief Summary:
ABSOLVE Biologic Wound Matrix is a combination of recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) and a bovine type I collagen wound dressing matrix. ABSOLVE is under development for the treatment of chronic and acute wounds. This study investigates the safety and efficacy of ABSOLVE in chronic diabetic foot ulcers (DFUs).

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Drug: RhPDGF-BB Other: Placebo Phase 2

Detailed Description:

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
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Becaplermin

Arm Intervention/treatment
Experimental: ABSOLVE
Type I collagen sheet soaked in a solution containing rhPDGF-BB.
Drug: 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.
Other: Placebo
Collagen Wound Dressing wetted with buffer.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Wound Size [ Time Frame: Week 0 - 24 ]
    The percent change in wound size (closure) over time.

  2. Wound Closure [ Time Frame: Week 0 - 24 ]
    Percent incidence of complete wound closure over time.

  3. Complication rate [ Time Frame: Week 0 - 24 ]
    Reduction in complications.



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 30 to 75 years of age
  • A diagnosis of Type 1 or 2 diabetes with HbAlc between 6 and 12%, an adequate blood supply defined as TcpO2 > 30 mmHg or an ankle brachial index (ABI) ≥ 0.7 on the foot with the target ulcer
  • A DFU 2 cm2-14 cm2 that extends into the subcutaneous tissues or beyond (≤Wagner Grade 2)
  • A DFU of at least 6 weeks duration and under care of the study investigator for at least 2 weeks following standard wound debridement with less than 30% healing
  • Body Mass Index (BMI) of 18.5 to 40 kg/m2
  • Co-morbidities are under control and non-life threatening as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests
  • A negative pregnancy test at Screening
  • Both males and WCBP agree to use acceptable contraceptive methods while on study
  • Able to comprehend and sign an ICF.

Exclusion Criteria:

  • Evidence of clinically significant findings on screening evaluations (clinical, laboratory, and ECG) which, in the opinion of the Investigator would pose a safety risk or interfere with interpretation of safety data
  • Current or recent history of significant bacterial, fungal, viral, or mycobacterial infection
  • History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
  • History of myocardial infarction, congestive heart failure, or stroke
  • History of psychotic disorder
  • History of alcoholism or drug addiction
  • Positive drug screen at Screening
  • Current treatment or treatment within 30 days prior to first dose of study products with another investigational drug or current enrollment in another clinical trial
  • Known history of HIV, hepatitis B, or hepatitis C
  • Known hypersensitivity to any of the product's components
  • Subjects who are unable or unlikely to comply with the protocol
  • Pregnant or lactating.

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): NCT03037970


Contacts
Contact: Sam Lynch, DMSc, DMD 615-218-1624 sam.lynch@lynchbiologics.com
Contact: Damon Michaels 615-724-4001 damon.michaels@medelis.com

Locations
Guatemala
Centro Medico Militar Recruiting
Guatemala City, Guatemala, 010116
Sponsors and Collaborators
Lynch Biologics LLC
Medelis Inc.
Centro Medico Militar
Investigators
Principal Investigator: Luis Gonzalez, MD Centro Medico Militar, Guatemala

Responsible Party: Lynch Biologics LLC
ClinicalTrials.gov Identifier: NCT03037970     History of Changes
Other Study ID Numbers: Lynch 02-01
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetic Foot
Ulcer
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Becaplermin
Angiogenesis Inducing Agents
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs