Evaluation of ABSOLVE in Diabetic Foot Ulcers

NCT03037970 | Unknown Phase 2

• 1 other identifier: Lynch 02-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Wound Size

  Week 0 - 24

• Wound Closure

  Week 0 - 24

• Complication rate

  Week 0 - 24

Study Arms (2)

ABSOLVE

EXPERIMENTAL

Type I collagen sheet soaked in a solution containing rhPDGF-BB.

Drug: RhPDGF-BB

Placebo

PLACEBO COMPARATOR

Collagen sheet soaked with saline solution.

Other: Placebo

Interventions

RhPDGF-BB DRUG

One 2x4x.3cm of collagen wound matrix is saturated with 2.0 ml of the rhPDGF-BB solution.

Also known as: ABSOLVE

ABSOLVE

Placebo OTHER

Collagen Wound Dressing wetted with buffer.

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lynch Biologics LLC: lead
• Medelis Inc.: collaborator
• Centro Medico Militar: collaborator

Study Sites (1)

Centro Medico Militar

Guatemala City, 010116, Guatemala

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

Becaplermin

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Proto-Oncogene Proteins c-sis; Platelet-Derived Growth Factor; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; DNA-Binding Proteins; Proteins; Biological Factors

Study Officials

• Luis Gonzalez, MD

  Centro Medico Militar, Guatemala

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sam Lynch, DMSc, DMD

CONTACT

615-218-1624; sam.lynch@lynchbiologics.com

Damon Michaels

CONTACT

615-724-4001; damon.michaels@medelis.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, blinded, two-arm, clinical study

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: January 31, 2017
• Study Start: January 30, 2017
• Primary Completion: August 15, 2017
• Study Completion: October 15, 2017
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

GU (1)