DFU, Diabetic Foot Ulcer, Diabetic Foot Ulcer (DFU), Foot Ulcer Due to Type 1 Diabetes Mellitus, Foot Ulcer Due to Type 2 Diabetes Mellitus, Ulcer, Ulcer Foot
Conditions
Brief summary
The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.
Detailed description
This study is a prospective modified platform multicenter randomized controlled clinical trial. The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.
Interventions
OTHERActivate™ Matrix
Participants will receive weekly applications of Activate™ Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHERAmnioDefend™ FT Matrix
Participants will receive weekly applications of AmnioDefend™ FT Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHERPalisade™ DM Matrix
Participants will receive weekly applications of Palisade™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHEREnclose™ TL Matrix
Participants will receive weekly applications of Enclose™ TL Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHERSentry™ SL Matrix
Participants will receive weekly applications of Sentry™ SL Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Shelter™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Sponsors
Sequence LifeScience, Inc.
Serena Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a multi-center, prospective, matched control clinical study trial evaluating placental derived allografts and standard of care versus standard of care alone in the treatment of nonhealing diabetic foot ulcers. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of one of seven CAMPs plus SOC for 12 weeks or until the study ulcer has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional for both arms, for the purpose of changing only the secondary dressing in the CAMP arm. The study utilizes a modified platform design adopted from clinical trials developed during the pandemic to simultaneously test multiple interventions in a single trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The potential subject must be at least 18 years of age or older. * The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus. * At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 15.0 cm2 measured post debridement with the imaging device length times width. * The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care, prior to the initial screening visit. * The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus. * The potential subject must have a target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone. * The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable: 1. ABI between 0.7 and ≤ 1.3; 2. TBI ≥ 0.6; 3. TCOM ≥ 40 mmHg; 4. PVR: biphasic. 8. If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and
Exclusion criteria
will be designated as the target ulcer. * The potential subject must have a target ulcer located on the 50% below the malleolus and not on the dorsal toes. * The ulcer must be offloaded for at least 14 days prior to enrollment. * The potential subject must consent to using the prescribed offloading method for the duration of the study. * The potential subject must agree to attend the weekly study visits required by the protocol. * The potential subject must be willing and able to participate in the informed consent process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Between-arm difference in subjects achieving complete closure | 1-12 Weeks | To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to closure | 1-12 weeks | To determine the between-arm difference in the time to closure over 12 weeks for CAMP plus SOC versus matched control subjects. |
| Percentage area reduction rate | 1-12 weeks | To determine the between-arm difference in percent area reduction (PAR) at weekly intervals for CAMP plus SOC versus matched control subjects. |
| Adverse Events | 1-12 Weeks | To determine the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus matched control subjects. |
| Determine quality of life | 1-12 weeks | To determine the between-arm difference in quality of life for subjects receiving CAMP plus SOC versus matched control subjects using the Forgotten Wound Score (FWS). The FWS is scored on a scale of 0-4. 0 being never and 4 being mostly. |
| Determine Quality of Life | 1-12 weeks | To determine the between-arm difference in quality of life for subjects receiving CAMP plus SOC versus matched control subjects Wound Quality of Life (wQOL) questionnaires. WQOL is scored 0-5. 0 being never and 5 being very much. |
Countries
United States
Contacts
CONTACTBennett Sarver
CONTACTThomas Serena, MD
Outcome results
None listed