Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers

ApoPharma

Status and phase

Terminated

Phase 3

Conditions

Diabetic Foot Ulcer

Treatments

Device: Dermal - Living Skin Replacement (Dermal - LSR)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00387101

RS03-2004

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of Dermal-LSR plus Standard of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment to SOC alone.

Full description

The study is a pivotal, prospective, randomized, controlled, open-label, multi-center study that will evaluate the effectiveness and safety of topically applied Dermal-LSR in chronic DFUs.

Enrollment

288 estimated patients

Sex

All

Ages

18 to 84 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Has signed a written informed consent prior to the first study intervention
Is at least 18 and <85 years of age
Has one or more diabetic foot ulcers on the target limb, with only one marked for the study (target ulcer). It must have the following characteristics:Plantar; Grade 2 per Curative Health Services Classification; Non-infected; Neuropathic; Non-malignant; At least 1.0-25cm^2 post-debridement; Present for at least 6 weeks
Has Type I or II Diabetes Mellitus with an HBA1c between 6-10%
Has a maximum fasting blood glucose level of 13.8 mmol/L
An ankle-brachial systolic pressure index between 0.7 and 1.3
If female and of childbearing potential has a negative serum pregnancy test and is neither breastfeeding or intending to become pregnant during the study
Able and willing to attend the scheduled visits and comply with study procedures.

Exclusion criteria

Known or suspected disease of the immune system
Active or untreated malignancy or active, uncontrolled connective tissue disease
Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment
Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement
Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to enrollment
Active febrile illness
AST, ALT, ALP >3x the normal upper limit
Serum Creatinine >2x the normal upper limit
Osteomyelitis
Active Charcot
Use of any topical treatments other than SOC (standard of care)at the time of enrollment
Enrollment in any investigational clinical trial within 30 days of the screening visit
Known or suspected hypersensitivity to any study product components
Recent or current history of alcohol or drug abuse
Any condition, which in the opinion of the Investigator, would interfere with the evaluation of the study product or poses a health risk to the subject
All site personnel directly affiliated with this study and their immediate families