Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ApoPharma
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.
Age
18–84
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers
