Evaluation of ABSOLVE in Diabetic Foot Ulcers (ABSOLVE)

A Prospective Randomized Controlled Blinded Study to Evaluate the Safety and Efficacy of rhPDGF-BB Saturated Collagen Wound Dressings on Diabetic Foot Ulcers

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).

Study Overview

• Status: Unknown
• Conditions: Diabetic Foot Ulcers
• Intervention / Treatment: Drug: RhPDGF-BB; Other: Placebo

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
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sam Lynch, DMSc, DMD; Phone Number: 615-218-1624; Email: sam.lynch@lynchbiologics.com
• Study Contact Backup: Name: Damon Michaels; Phone Number: 615-724-4001; Email: damon.michaels@medelis.com

Study Locations

• Guatemala
  • Guatemala City, Guatemala, 010116
    • Recruiting
    • Centro Medico Militar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: ABSOLVE
PLACEBO_COMPARATOR: Placebo; Collagen sheet soaked with saline solution.	Other: Placebo; Collagen Wound Dressing wetted with buffer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Determine safety and tolerability of ABSOLVE on patients having a poorly healing diabetic foot ulcer.	Week 0 - 24
Successful wound healing for at least two consecutive measurements. (Efficacy)	Successfully healed wound must remain closed for at least two consecutive measurements, one of which will be at the 12-week examination.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Size	The percent change in wound size (closure) over time.	Week 0 - 24
Wound Closure	Percent incidence of complete wound closure over time.	Week 0 - 24
Complication rate	Reduction in complications.	Week 0 - 24

Collaborators and Investigators

• Sponsor: Lynch Biologics LLC
• Collaborators: Medelis Inc.; Centro Medico Militar
• Investigators: Principal Investigator: Luis Gonzalez, MD, Centro Medico Militar, Guatemala

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 30, 2017
• Primary Completion (ANTICIPATED): August 15, 2017
• Study Completion (ANTICIPATED): October 15, 2017

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (ESTIMATE): January 31, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Physiological Effects of Drugs; Angiogenesis Modulating Agents; Growth Substances; Anticoagulants; Angiogenesis Inducing Agents; Becaplermin
• Other Study ID Numbers: Lynch 02-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No