Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStimLabs
About this trial
The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years of age or older.
Diagnosis of type 1 or 2 Diabetes mellitus.
At enrollment, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 25.0 cm2 measured post debridement with the MolecuLight® Imaging Device.
The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
Disqualifiers
Target ulcers located on the plantar aspect of the foot 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.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard of Care
Other interventionBeginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Revita
Other interventionParticipants will receive weekly applications of Revita and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Relese
Other interventionParticipants will receive weekly applications of Relese and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Cogenex
Other interventionParticipants will receive weekly applications of Cogenex and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Enverse
Other interventionParticipants will receive weekly applications of Enverse and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Treatment groups
272 Participants
are divided into 5 treatment groupsGroup A: Standard of CareActive comparator 1 intervention
Group B: RevitaExperimental treatment 1 intervention
Group C: ReleseExperimental treatment 1 intervention
Group D: CogenexExperimental treatment 1 intervention
Group E: EnverseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The percentage of target ulcers achieving complete wound closure
Determine the percent of target ulcers achieving complete wound closure at 12 weeks. In addition, a qualified third-party clinician will independently confirm wound closure.
Time frame
1-12 weeksSecondary outcomes
1
Time to closure for the target ulcer
Time to closure will be determined for each treatment group and compared to SOC.
Time frame
1-12 weeks2
Percent area reduction
Percent Area Reduction (PAR) will be calculated from Treatment Visit (TV)-1 to Treatment Visit (TV)-13.
Time frame
1-12 weeks3
Adverse events
Incidence of adverse events will be evaluated weekly from TV-1 to the healing confirmation visit (HCV).
Time frame
1-14 weeks4
Change in pain in target ulcer
Change in target ulcer pain assessed using the Pain, Enjoyment of Life and General Activity (PEG) scale (0 to 10 where higher score indicates more severe pain and pain-related interference with life and activities) at TV-1, TV-4, TV-7, TV-10, and TV-13.
Time frame
1-14 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
StimLabs
Lead sponsor
SerenaGroup, Inc.
Collaborator
Source ClinicalTrials.gov