AIC + Standard Care for Foot Ulcer

(ELITE Trial)

Recruiting at 8 trial locations

Overseen By Bryanna Finstein, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Cellution Biologics

Must not be taking: Immunosuppressants, Cytotoxic chemotherapy

Disqualifiers: Infected ulcer, Osteomyelitis, Charcot foot, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for diabetic foot ulcers using a product made from human placental tissue, called Amnion-Intermediate-Chorion (AIC), alongside usual foot care practices. The goal is to determine if this combination heals foot ulcers more effectively than usual care alone. People with diabetes who have had a foot ulcer for at least four weeks and do not have complications like infection may be suitable for this study. Participants will receive treatment until their ulcer heals or for up to 12 weeks. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants or certain steroids, you may not be eligible to participate.

What is the safety track record for the Amnion-Intermediate-Chorion treatment?

Research has shown that the Amnion-Intermediate-Chorion (AIC) treatment has produced positive results in previous studies. One study found that similar dried human placental tissue helped wounds heal faster in patients with hard-to-treat diabetic foot ulcers. These results suggest the treatment is generally well-tolerated.

Another study on dried human placental tissue found that many patients' ulcers healed completely within 12 weeks, with no major safety issues reported. This suggests it may be a safe option.

Since this trial is in a later stage, the treatment has likely undergone previous testing, which usually means more is known about its safety. Overall, the evidence so far suggests that AIC could be a reliable and safe treatment for healing diabetic foot ulcers. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Amnion-Intermediate-Chorion (AIC) treatment for diabetic foot ulcers because it uses a unique material derived from human placental tissue. Unlike the standard care options, which typically involve cleaning, debridement, moisture balance, and offloading, AIC introduces a biologically active treatment that may enhance healing. This novel approach aims to not just manage the condition but potentially accelerate the body's natural healing process, offering hope for quicker and more complete ulcer closure.

What evidence suggests that Amnion-Intermediate-Chorion is effective for diabetic foot ulcers?

This trial will compare the effectiveness of Amnion-Intermediate-Chorion (AIC) sheets combined with standard care to standard care alone for diabetic foot ulcers. Studies have shown that AIC sheets can accelerate the healing of these ulcers. Specifically, one study found that more foot ulcers healed completely in 12 weeks when treated with dehydrated human placental tissue compared to standard care alone. Additional research has demonstrated that human amniotic membrane products outperform standard wound care for these ulcers. These treatments create a protective barrier and encourage tissue growth, promoting faster wound healing. Overall, strong evidence supports the effectiveness of AIC in treating diabetic foot ulcers. ^{2 3 4 6 7}

Who Is on the Research Team?

Research Director

Principal Investigator

Cellution Biologics

Are You a Good Fit for This Trial?

Adults over 18 with type 1 or type 2 diabetes and a nonhealing foot ulcer present for at least 4 weeks can join. The ulcer should be on the foot, below the ankle, and not expose tendon or bone. Participants need controlled diabetes (HbA1c <12%) and adequate blood flow to their feet as shown by specific tests.

Inclusion Criteria

Hemoglobin A1c (HbA1c) level is less than 12% (108 mmol/mol)

I have more than one ulcer, and they are at least 2 cm apart.

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

Exclusion Criteria

Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments

Known sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics

Participation in a clinical trial involving treatment with an investigational product within the previous 30 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive weekly treatment with either Amnion-Intermediate-Chorion (AIC) and Standard of Care or Standard of Care alone until ulcer closure or a maximum of 12 weeks

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Amnion-Intermediate-Chorion

Trial Overview The trial is testing if adding Dehydrated Human Placental Tissue (dHPT) to standard wound care helps heal diabetic foot ulcers better than just standard care alone. Patients will either receive this additional treatment or they'll stick with only the usual wound care methods.

How Is the Trial Designed?

Group I: AIC and Standard of Care Experimental Treatment 2 Interventions

Participants with a diabetic foot ulcer (DFU) will receive treatment with an Amnion-Intermediate-Chorion (AIC) sheet product, a dehydrated multilayer human placental tissue derived from donated human tissue, and 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.

Group II: Standard of Care Active Control 1 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.

Who Is Running the Clinical Trial?

Cellution Biologics

Lead Sponsor

Trials

1

Recruited

290+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7379535/

A confirmatory study on the efficacy of dehydrated human ... The primary study outcome was percentage of study ulcers completely healed in 12 weeks, with both ITT and per‐protocol participants receiving weekly dHACM ...

2. magonlinelibrary.com magonlinelibrary.com/doi/10.12968/jowc.2025.0022

Clinical outcomes of lyophilised human amnion/chorion ... Conclusion: LHACM demonstrated effectiveness in accelerating wound closure in complex hard-to-heal DFUs resistant to SoC, highlighting its ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1056872720303974

Glycemic control and diabetic foot ulcer outcomes Our findings suggest that A1C levels ≥8% and fasting glucose levels ≥126 mg/dl are associated with increased likelihood of LEA in patients with DFUs.

4. jfootankleres.biomedcentral.com jfootankleres.biomedcentral.com/articles/10.1186/s13047-022-00575-y

Human amniotic membrane products for patients with diabetic ... Many studies have shown that DHACA as a treatment for diabetic foot ulcers is more effective than standard wound care alone. For further ...

5. drc.bmj.com drc.bmj.com/content/11/2/e003110

Evaluating the prognostic performance of bedside tests ... Results 123 of TrEAD participants with DFU were included. In 12 months, 52.8% of ulcers healed. The best negative diagnostic likelihood ratio ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12230948/

Determinants of enrolment rate in 397 clinical trials for ... The systematic review was based on comprehensive data, consisting of 397 diabetic foot ulcer (DFU) clinical trials reported since 1990, to ...

7. trial.medpath.com trial.medpath.com/clinical-trial/e8dcadc4e16b8838/nct07014176-dehydrated-human-placenta-dhpt-diabetic-foot-ulcers

Nonhealing Diabetic Foot Ulcers Treated With Standard of ... This study will evaluate the clinical utility of Amnion-Intermediate-Chorion (AIC) in the closure of diabetic foot ulcers in subjects in comparison to Standard ...