Status:Not yet recruiting
Keywords:Non-healing foot Ulcers , Diabetes mellitus
The Primary Objective of the study is to demonstrate the increased incidence of complete wound closure up to 10 weeks confirmed 2 weeks later, and remaining closed until 12 weeks by DSC127 compared to the vehicle in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 1 - 6 cm2 in size. Complete wound closure is defined as complete skin re-epithelialization without drainage or dressing requirements. Confirmed complete wound closure is defined as complete skin re-epithelialization without drainage or dressing requirements confirmed at a study visit 2 weeks later.
The secondary objective of the study is:
● To demonstrate the increased incidence of complete wound closure up to 10 weeks confirmed 2 weeks later and remaining closed until 12 weeks by DSC127 compared to the standard of care gel (AQUASITE®) in subjects with DM who have chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 1 - 6 cm2 in size.
● To assess the incidence of complete wound closure up to 10 weeks confirmed 2 weeks later and remaining closed until 12 weeks by vehicle compared to the standard of care gel in subjects with DM who have chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 1 - 6 cm2 in size.
● To evaluate the safety of DSC127 including adverse events (AEs) and serious adverse events (SAEs) (if any), clinical laboratory results, electrocardiograms (ECGs), and vital signs
● To assess the status of the DFU being treated by evaluation of the skin surrounding the DFU (presence of erythema, edema, cellulitis, callus, maceration), the wound drainage (including amount, purulence and odor), and wound bed surface (necrotic tissue, fibrin slough, granulation tissue, and epithelium)
A subject who meets all the following criteria will be included in the study:
1. Male or female ambulatory subject age ≥18 years at the time of informed consent.
2. Has type 1 or type 2 DM under metabolic control as confirmed by a glycosylated hemoglobin (HbA1c) of ≤12% and a serum creatinine level of ≤3mg/dL.
3. At Screening, subject has at least one chronic non-healing Wagner Grade 1 or Grade 2 target ulcer that fulfills all of the following criteria:
o If more than one ulcer is present that meets the inclusion criteria, the largest one will be considered the target ulcer
o Non-target ulcers will also be treated according to standard of care (Acute Charcot Neuroarthropathy must be excluded)
4. Has an ankle brachial index (ABI) >0.7 for neuroischemic or >0.8 for a neuropathic DFU
5. Has an assessment of the baseline level of neuropathy of the foot using Semmes-Weinstein filaments. -A subject will be considered to have site-specific neuropathy sufficient for loss of protective sensation (LOPS) if he/she is unable to feel a 5.07 Semmes-Weinstein monofilament applied to at least five of the
following seven sites on the study foot:
o Plantar to toes and metatarsals 1, 3, and 5 (three sites)
o Plantar to midfoot medial and lateral (two sites)
o Plantar heel (one site)
o Dorsal distal first interspace (one site)
6. A female subject of childbearing potential must have a negative serum pregnancy test at the time of Screening.
7. A female subject of childbearing potential must be willing to use a medically acceptable method of birth control, such as Essure®, hormonal contraception (oral pills, implantable device, or skin
patch), intrauterine device, tubal ligation, or double barrier throughout the study. A female subject of childbearing potential who practices abstinence is not required to employ birth control.
8. Has the ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study or initiation of study procedures
1. Has a known hypersensitivity to any of the investigational drug or vehicle or standard of care gel components.
2. Has been exposed to any investigational agent within 30 days of entry into the study.
3. A female who is pregnant or nursing.
4. Has active malignant disease of any kind. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.
5. Has a history of additional risk factors for Torsade de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome, QT>450 msec at baseline)
6. Has a hemoglobin of less than 10 gm/dL.
7. Has chronic liver dysfunction evidenced by transaminase levels greater than 2 × normal.
8. Is receiving hemodialysis or chronic ambulatory peritoneal dialysis (CAPD) therapy.
9. Has had prior radiation therapy to any part of the foot with the target ulcer under study.
10. Current use of corticosteroids and immunosuppressants (within the past 8 weeks).
11. Has an ulcer primarily ischemic in etiology as diagnosed by anABI of <0.7 or great toe systolic pressure <50 mmHg or a tissue oxygen pressure (TcPO2) <40 mmHg in the supine position and
<40 mmHg while sitting, measured on the forefoot with electrode set at 44 C.
12. Has sickle-cell anemia, Reynaud's, or peripheral vascular disease.
13. Has received a biologic agent, growth factor, or skin equivalents (Regranex®, Apligraft, or Dermagraft), in the past 30 days.
14. Has a target ulcer which is determined to be clinically infected or requires topical antimicrobials or agents known to affect wound healing or has been taking systemic antibiotics for more than 7
days for any reason.
15. Has a Wagner Grade 3 or higher DFU, deep abscess, or gangrene.
16. Has a baseline blood pressure (BP) reading >160 systolic and/or >90 diastolic mmHg. If >160 systolic or >90 diastolic mmHg at the first measurement, three additional readings will be performed at 15-minute intervals. If the BP is consistently above 160 systolic and/or 90 diastolic, the subject will be excluded.