Diabetic Foot Ulcers
Conditions
Interventions
Product Name: Aclerastide
Product Code: DSC127
Pharmaceutical Form: Gel
Pharmaceutical form of the placebo: Gel
Route of administration of the placebo: Topical use (Noncurrent)
Trade Name: AQUASITE®
Sponsors
Derma Sciencs Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 and at Baseline (prior to randomization), subject has at least ulcer that fulfills all of the following criteria: a) present for =1 month and = 1year. b) Partial- or full- thickness and not involving bone, tendon, or capsule (probing to tendon or capsule), i.e., Wagner Grade 1 or 2. c) Has no sign of infection or osteomyelitis d) Plantar neuropathic ulcer - The ulcer must predominately be on the plantar surface (i.e., weight bearing) of the foot to ensure adequate off-loading, and may include the toes but edges of the ulcer may be extended to the sides of the foot. e) Size of the target ulcer must be 0.75 - 6 cm.2 f) Target ulcer must be non-healing as defined as 0.7 on the leg of the foot with the target ulcer. 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 in 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: A subject satisfying any of the following criteria will be excluded from participating in the study: 1. Has a known hypersensitivity to any of the investigational drug or vehicle 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 except for basal cell carcinoma (of the skin). 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 hemoglobin of less than 8.5 gm/dL. 6. Transaminase levels greater than 3x normal. 7. Is receiving hemodialysis or chronic ambulatory peritoneal dialysis (CAPD) therapy. 8. Has had prior radiation therapy of any part of the foot with the target ulcer under study. 9. Use of systemic corticosteroids or immunosuppressants (within the 8 weeks prior to screening). 10. Has an ulcer primarily ischemic in etiology as diagnosed by an ABI of <0.7 on the affected extremity or great toe systolic pressure <50 mmHg or a transcutaneous oxygen pressure (TcPO2) <40 mmHg in the supine position and <40 mmHg while sitting, measured on the forefoot with electrode set at 44 C on the affected foot. 11. Has sickle-cell anemia, Reynaud's, or other peripheral vascular disease. 12. Has received a biologic agent to include growth factors and skin equivalents (Regranex®, Apligraft, or Dermagraft), in the past 30 days. 13. Has a target ulcer which is determined to be clinically infected and requires antimicrobials. Any antibiotic therapy must be completed or discontinued at screening. 14. Has a Wagner Grade 3 or greater DFU, deep abscess, or gangrene. 15. Has uncontrolled hypertension, in the opinion of the Investigator. 16. Any other finding, which in the opinion of the Investigator, may interfere with the assessment of the product or participation of the subject in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective The primary objective of the study is to demonstrate the increased incidence of complete wound closure by 10 weeks confirmed 2 weeks later by Aclerastide (DSC127) compared to the vehicle in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 0.75 - 6 cm2 in size. Complete wound closure is defined as complete skin re-epithelialization without drainage or dressing requirements. Complete closure will be confirmed at a study visit 2 weeks later. ;Secondary Objective: The secondary objectives of the study are: ? To demonstrate the increased incidence of complete wound closure by 10 weeks confirmed 2 weeks later by Aclerastide (DSC127) compared to the Standard of Care (SOC) gel (AQUASITE®) in subjects with DM who have chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 0.75 - 6 cm2 in size. ? To assess the similarity of response between vehicle and SOC gel for incidence of complete wound closure up to 10 weeks, confirmed 2 weeks later, in subjects with DM who have chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 0.75 - 6 cm2 in size. ;Primary end point(s): The efficacy analyses will address the issue of controlling the error rate for the comparison of Aclerastide (DSC127) 0.03% to each of the controls using the Gatekeeping approach, where Aclerastide (DSC127) 0.03% is compared first to the vehicle group which gate-keeps for the comparison of Aclerastide (DSC127) 0.03% to the standard of care, thus maintaining the alpha at 0.05 (two-tailed). Between control group (vehicle and standard of care) comparisons will also be performed as part of the descriptive summary of results. The analysis for the primary and secondary objectives, the proportion of subjects with confirmed complete wound closure by 12 weeks, will be analyzed using a mixed methods logistic regression model which will include the stratification factors of ulcer size at Baseline and ulcer grade as we | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The efficacy analyses will address the issue of controlling the error rate for the comparison of Aclerastide (DSC127) 0.03% to each of the controls using the Gatekeeping approach, where Aclerastide (DSC127) 0.03% is compared first to the vehicle group which gate-keeps for the comparison of Aclerastide (DSC127) 0.03% to the standard of care, thus maintaining the alpha at 0.05 (two-tailed). Between control group (vehicle and standard of care) comparisons will also be performed as part of the descriptive summary of results. The analysis for the primary and secondary objectives, the proportion of subjects with confirmed complete wound closure by 12 weeks, will be analyzed using a mixed methods logistic regression model which will include the stratification factors of ulcer size at Baseline and ulcer grade as well as, study site and the covariates of duration of target ulcer and subject age. Study sites (pooled) will be treated as a random effect to account for possible correlation between subjects within a site. ;Timepoint(s) of evaluation of this end point: • Time to the visit where the target ulcer achieves confirmed complete wound closure occurs (skin re-epithelialization without drainage or dressing requirements confirmed at a study visit 2 weeks later) | — |
Countries
Estonia, Hungary, Latvia, South Africa, Ukraine, United States
Contacts
Public ContactDr Oleg Polnjak
Clinical Research Foundation eeu
Outcome results
None listed