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Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs

ConditionsPathologic ProcessesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseaseDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesDiabetes ComplicationsDiabetic NeuropathiesFoot DiseasesDiabetic FootFoot UlcerDiabetes Mellitus, Type 2UlcerFoot Ulcer Unhealed
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorC5 Biomedical

About this trial

The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years of age or older.

Must have diagnosis of type 1 or 2 Diabetes mellitus.

At enrollment, subject must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the imaging device.

Must have a target ulcer that has been present for a minimum of 4 weeks and maximum of 52 weeks of standard of care, prior to screening visit.

Disqualifiers

Target ulcer must be located on the plantar aspect of the foot and must be offloaded for at least 14 days prior to enrollment.

Subject must consent to using the prescribed offloading method for the duration of the study.

Subject must agree to attend weekly study visits.

Subject must be willing and able to participate in the consent process.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard of Care - DFU

    Other intervention

    Beginning 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.

  • AM/Single - DFU

    Other intervention

    Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

  • AM/Double - DFU

    Other intervention

    Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

  • Standard of Care - VLU

    Other intervention

    Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

  • AM/Single - VLU

    Other intervention

    Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

  • AM/Double - VLU

    Other intervention

    Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Treatment groups

177 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Standard of Care - DFUActive comparator 1 intervention
Group B: AM/Single - DFUExperimental treatment 1 intervention
Group C: AM/Double - DFUExperimental treatment 1 intervention
Group D: Standard of Care - VLUActive comparator 1 intervention
Group E: AM/Single - VLUExperimental treatment 1 intervention
Group F: AM/Double - VLUExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Determine the percentage of subjects achieving complete closure of target ulcer over 12 weeks.

The proportion of subjects achieving complete wound closure of target ulcer.

Time frame
1-12 weeks

Secondary outcomes

1

Time to closure for target ulcer.

Length of time in days to closure will be determined for each treatment group and compared to SOC alone.

Time frame
1-12 weeks
2

Percent Area Reduction (PAR)

Percent Area Reduction (PAR) will be calculated from Treatment Visit (TV)-1 to TV-13 measured weekly with digital photographic planimetry, using imaging device, and physical examination.

Time frame
1-12 weeks
3

Adverse Events

Determine number of adverse events

Time frame
1-12 weeks
4

Change in pain in target ulcer

Change in pain in target ulcer assessed using the Pain, Enjoyment of Life and General Activity (PEG) scale

Time frame
1-12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

C5 Biomedical

Lead sponsor

SerenaGroup, Inc.

Collaborator

Source ClinicalTrials.gov
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