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Living Cellular Skin Substitute

Advanced Wound Care Products for Chronic Wounds

Q: How many settings are utilizing this clinical experiment?

For this clinical trial, five medical facilities are actively recruiting patients. These include Methodist Physicians Clinic in Omaha, Rush University Medical Center in Chicago and Gundersen Health System in La Crosse; two additional sites have yet to be disclosed.

Q: Is there still room for participants in this investigation?

Affirmative. According to the information on clinicaltrials.gov, recruitment for this medical trial is still ongoing since its initial posting on July 19th 2021 and last update on October 24th 2022. 170 patients are needed from 5 different locations across America.

Q: How many volunteers have been recruited for participation in this clinical trial?

Acera Surgical, Inc. has established that 170 eligible participants must be enrolled in order to carry out the trial at sites such as Methodist Physicians Clinic (Omaha, <a href="https://www.withpower.com/clinical-trials/nebraska">Nebraska</a>) and Rush University Medical Center (Chicago, <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a>).

N/A

Waitlist Available

Research Sponsored by Acera Surgical, Inc.

Eligibility Criteria Checklist

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

Must have

Ulcer(s) must be located at least in part on the foot or ankle

Wound size must be >1.0 cm^2 and < 25 cm^2 on the day of randomization and initial application of the study product, after initial debridement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to six months

Awards & highlights

Study Summary

This trial will compare two different treatments for diabetic and venous leg ulcers to see which one is more effective in promoting complete wound closure.

Who is the study for?

This trial is for adults over 18 with diabetic foot ulcers or venous leg ulcers that have persisted for more than 28 days and are between 1.0 cm^2 and <25 cm^2 in size. Participants must have Type 1 or Type 2 diabetes with good blood flow to the affected limb, as shown by specific tests. They cannot be on certain steroids, have other close wounds, be pregnant, or have allergies to suture materials.Check my eligibility

What is being tested?

The study compares a new treatment called Restrata® (a synthetic hybrid-scale fiber matrix) against standard care for diabetic foot ulcers and against Apligraf® (a living cellular skin substitute) for venous leg ulcers. The goal is to see which treatment better achieves complete wound closure.See study design

What are the potential side effects?

Potential side effects may include local reactions at the application site such as redness, pain, or irritation; allergic reactions if sensitive to material components; and infection risks due to open wounds.

Eligibility Criteria

Inclusion Criteria

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

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My ulcer is located on my foot or ankle.

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My wound is larger than 1 cm^2 but smaller than 25 cm^2.

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

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to six months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to six months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to six months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

For Participants With Diabetic Foot Ulcers, number of participants with 100 Percent Epithelialization (Closure) of Wound

For Participants With Venous Leg Ulcers, number of participants with 100 Percent Epithelialization (Closure) of Wound

Secondary outcome measures

Decrease in Wound Area

Number of Product Applications

Time to 100 Percent Epithelialization

Other outcome measures

Cost Effectiveness

Investigator's Rating of the Ease of Use and Handling of Study Product

Number of Adverse Events Related to the Study Product and/or Procedure

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)Experimental Treatment1 Intervention

Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)

Group II: Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)Experimental Treatment1 Intervention

Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)

Group III: Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)Active Control1 Intervention

Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)

Group IV: Diabetic Foot Ulcer Participants Assigned to Standard of CareActive Control1 Intervention

Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Acera Surgical, Inc.Lead Sponsor

5 Previous Clinical Trials

86 Total Patients Enrolled

2 Trials studying Foot Ulcer

76 Patients Enrolled for Foot Ulcer

Media Library

Foot Ulcer Research Study Groups: Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®), Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®), Diabetic Foot Ulcer Participants Assigned to Standard of Care, Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)

Living Cellular Skin Substitute (Living Cellular Skin Substitute) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04927702 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many settings are utilizing this clinical experiment?

"For this clinical trial, five medical facilities are actively recruiting patients. These include Methodist Physicians Clinic in Omaha, Rush University Medical Center in Chicago and Gundersen Health System in La Crosse; two additional sites have yet to be disclosed."

Answered by AI

Is there still room for participants in this investigation?

"Affirmative. According to the information on clinicaltrials.gov, recruitment for this medical trial is still ongoing since its initial posting on July 19th 2021 and last update on October 24th 2022. 170 patients are needed from 5 different locations across America."

Answered by AI

How many volunteers have been recruited for participation in this clinical trial?

"Acera Surgical, Inc. has established that 170 eligible participants must be enrolled in order to carry out the trial at sites such as Methodist Physicians Clinic (Omaha, Nebraska) and Rush University Medical Center (Chicago, Illinois)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)

2021. "Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04927702.