Diabetic Foot Ulcer
Conditions
Keywords
Diabetic Foot Ulcer, Diabetes Mellitus, Debridement, Dermal-LSR, Standard of Care
Brief summary
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.
Detailed 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.
Interventions
DEVICEDermal - Living Skin Replacement (Dermal - LSR)
Sponsors
ApoPharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the efficacy and safety of Dermal-LSR plus Standard of Care (SOC) for the treatment of chronic diabetic foot ulcers in comparison to treatment with SOC alone. | — |
Countries
United States
Outcome results
None listed