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Evaluation of ABSOLVE in Diabetic Foot Ulcers (ABSOLVE)

Primary Purpose

Diabetic Foot Ulcers

Status

Unknown status

Phase

Phase 2

Locations

Guatemala

Study Type

Interventional

Intervention

RhPDGF-BB

Placebo

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcers

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Centro Medico MilitarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ABSOLVE

Placebo

Arm Description

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

Collagen sheet soaked with saline solution.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

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)

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

Wound Size

The percent change in wound size (closure) over time.

Wound Closure

Percent incidence of complete wound closure over time.

Complication rate

Reduction in complications.

Full Information

NCT ID

NCT03037970

First Posted

January 26, 2017

Last Updated

January 30, 2017

Sponsor

Lynch Biologics LLC

Collaborators

Medelis Inc., Centro Medico Militar

1. Study Identification

Unique Protocol Identification Number

NCT03037970

Brief Title

Evaluation of ABSOLVE in Diabetic Foot Ulcers

Acronym

ABSOLVE

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 30, 2017 (Anticipated)

Primary Completion Date

August 15, 2017 (Anticipated)

Study Completion Date

October 15, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lynch Biologics LLC

Collaborators

Medelis Inc., Centro Medico Militar

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

This is a randomized, blinded, two-arm, clinical study

Masking

ParticipantInvestigator

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.

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ABSOLVE

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Collagen sheet soaked with saline solution.

Intervention Type

Drug

Intervention Name(s)

RhPDGF-BB

Other Intervention Name(s)

ABSOLVE

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Collagen Wound Dressing wetted with buffer.

Primary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Description

Determine safety and tolerability of ABSOLVE on patients having a poorly healing diabetic foot ulcer.

Time Frame

Week 0 - 24

Title

Successful wound healing for at least two consecutive measurements. (Efficacy)

Description

Successfully healed wound must remain closed for at least two consecutive measurements, one of which will be at the 12-week examination.

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Wound Size

Description

The percent change in wound size (closure) over time.

Time Frame

Week 0 - 24

Title

Wound Closure

Description

Percent incidence of complete wound closure over time.

Time Frame

Week 0 - 24

Title

Complication rate

Description

Reduction in complications.

Time Frame

Week 0 - 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sam Lynch, DMSc, DMD

Phone

615-218-1624

sam.lynch@lynchbiologics.com

First Name & Middle Initial & Last Name or Official Title & Degree

Damon Michaels

Phone

615-724-4001

damon.michaels@medelis.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luis Gonzalez, MD

Organizational Affiliation

Centro Medico Militar, Guatemala

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centro Medico Militar

City

Guatemala City

ZIP/Postal Code

010116

Country

Guatemala

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Evaluation of ABSOLVE in Diabetic Foot Ulcers

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