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Evaluation of ABSOLVE in Diabetic Foot Ulcers

NCT ID: NCT03037970

Last Updated: 2017-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-30

Study Completion Date

2017-10-15

Brief Summary

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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

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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.

Conditions

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Diabetic Foot Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized, blinded, two-arm, clinical study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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ABSOLVE

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

Group Type EXPERIMENTAL

RhPDGF-BB

Intervention Type DRUG

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

Placebo

Collagen sheet soaked with saline solution.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Collagen Wound Dressing wetted with buffer.

Interventions

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RhPDGF-BB

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

Intervention Type DRUG

Placebo

Collagen Wound Dressing wetted with buffer.

Intervention Type OTHER

Other Intervention Names

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ABSOLVE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medelis Inc.

INDUSTRY

Sponsor Role collaborator

Centro Medico Militar

UNKNOWN

Sponsor Role collaborator

Lynch Biologics LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luis Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Medico Militar, Guatemala

Locations

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Centro Medico Militar

Guatemala City, , Guatemala

Site Status RECRUITING

Countries

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Guatemala

Central Contacts

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Sam Lynch, DMSc, DMD

Role: CONTACT

Phone: 615-218-1624

Email: [email protected]

Damon Michaels

Role: CONTACT

Phone: 615-724-4001

Email: [email protected]

Other Identifiers

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Lynch 02-01

Identifier Type: -

Identifier Source: org_study_id