30 Participants Needed

Placental Membrane Dressings for Foot Ulcer

Recruiting at 1 trial location
JA
Overseen ByJosh Arnold
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Evaluation of Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing

Are You a Good Fit for This Trial?

This trial is for adults with Type 1 or Type 2 diabetes who have a diabetic foot ulcer (DFU) below the ankle, sized between 1.0 cm² and 20.0 cm² that's been present for at least four weeks but no more than one year. The ulcer should not be healing well on its own and must not show exposed muscle or bone.

Inclusion Criteria

My foot ulcer has not shrunk by 30% despite treatment.
Patient has signed the informed consent form
My foot ulcer has been present for 4 weeks to 12 months.
See 6 more

Exclusion Criteria

Pregnant or lactating women
Hemoglobin A1c (HbA1c) level is > 10%
I have been taking more than 7.5 mg of oral steroids daily for the last month.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive placental membrane dressings to evaluate their efficacy in accelerating diabetic foot healing

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Placental Membrane

Trial Overview

The study tests if placental membrane dressings can speed up the healing of diabetic foot ulcers compared to standard treatments. Participants will receive these special dressings to see if their wounds heal faster.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Placental Membrane DressingExperimental Treatment1 Intervention
Group II: Historical ControlsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

BioXTek

Lead Sponsor