← Back to Search

Skin Substitute

Skin Substitutes + Standard Care for Diabetic Foot Ulcers (CAMPSTIM Trial)

N/A

Recruiting

Research Sponsored by StimLabs

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of type 1 or 2 Diabetes mellitus

At least 18 years of age or older

Must not have

Taking hydroxyurea

Target ulcer exposes tendon or bone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-14 weeks

Awards & highlights

Summary

This trial aims to see if using four different types of skin substitutes made from human placental membrane along with standard care is better at healing diabetic foot ulcers compared to standard care alone.

Who is the study for?

This trial is for individuals with hard-to-heal diabetic foot ulcers. Participants should meet specific health criteria to be eligible, but the provided information does not detail these requirements.

What is being tested?

The study tests the effectiveness of four skin substitutes (Enverse, Cogenex, Revita, Relese) plus standard wound care against just standard wound care in healing diabetic foot ulcers over a period of 12 weeks.

What are the potential side effects?

Potential side effects are not specified in the provided information. Generally, treatments like skin substitutes may cause local reactions such as redness or discomfort at the application site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with type 1 or type 2 diabetes.

Select...

I am 18 years old or older.

Select...

My ulcer is between 1.0 and 25.0 cm2 after cleaning and measured with a special device.

Select...

My foot ulcer is mostly below my ankle.

Select...

My ulcer is deep but does not show any exposed bone.

Select...

Blood flow in my affected limb is confirmed to be good.

Select...

My foot ulcer has been pressure-free for at least 2 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently taking hydroxyurea.

Select...

My ulcer exposes tendon or bone.

Select...

My wound is complicated by a bone infection.

Select...

My ulcer is not caused by diabetes.

Select...

My wound or the skin around it is infected.

Select...

I am currently on antibiotics for an infection.

Select...

I am taking medication that affects my immune system or wound healing.

Select...

I have a deformity from a partial amputation that affects my ability to walk or stand properly.

Select...

I have a foot condition that makes it hard to reduce pressure on my foot.

Select...

I am on dialysis for end-stage kidney disease.

Select...

My ulcer was treated with special oxygen therapy or a specific wound product in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The percentage of target ulcers achieving complete wound closure

Secondary study objectives

Adverse events

Change in pain in target ulcer

Determine improvement in Quality of Life - FWS

+3 more

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: RevitaExperimental Treatment1 Intervention

Revita is an opaque, lyophilized dehydrated complete human placental membrane (dCHPM) allograft.

Group II: ReleseExperimental Treatment1 Intervention

Relese is a fenestrated dehydrated complete human placental membrane (dCHPM) allograft.

Group III: EnverseExperimental Treatment1 Intervention

Enverse is a translucent dehydrated complete human placental membrane (dCHPM) allograft.

Group IV: CogenexExperimental Treatment1 Intervention

Cognenex is a fenestrated dehydrated complete human placental membrane (dCHPM) allograft.

Group V: Standard of CareActive Control1 Intervention

Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading.

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

StimLabsLead Sponsor

3 Previous Clinical Trials

87 Total Patients Enrolled

1 Trials studying Foot Ulcer

9 Patients Enrolled for Foot Ulcer

SerenaGroup, Inc.NETWORK

28 Previous Clinical Trials

2,986 Total Patients Enrolled

14 Trials studying Foot Ulcer

1,683 Patients Enrolled for Foot Ulcer

~181 spots leftby Jun 2026

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.