Cellular and Matrix Products for Diabetic Foot and Venous Leg Ulcers

(CAMPLIFE Trial)

Not currently recruiting at 12 trial locations

Overseen By Cellution Clinical

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Cellution Biologics

Must not be taking: Immunosuppressants, Cytotoxic chemotherapy, Biologics

Disqualifiers: Infection, Osteomyelitis, Pregnancy, 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: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new treatments for individuals with diabetic foot ulcers and venous leg ulcers. It compares special placental tissue products, such as Amnion-Chorion-Amnion and Amnion-Intermediate-Chorion, to standard care (regular cleaning and bandaging) to determine which is more effective for healing these wounds. Individuals who have had their ulcer for at least four weeks without much improvement might be suitable for this study. Participants will receive weekly treatments for up to 12 weeks or until their ulcer heals. As a Phase 4 trial, this study involves treatments that are already FDA-approved and proven effective, aiming to understand how they can benefit 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, high-dose corticosteroids, or certain chemotherapy drugs, you may not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that using amniotic and chorion tissues in treatments has been safe in past studies. For the Amnion-Intermediate-Chorion (AIC) treatment used on diabetic foot ulcers (DFUs), studies have found that these tissue products are well-tolerated and help ulcers heal faster with fewer complications than traditional treatments.

For venous leg ulcers (VLUs), similar positive results have been observed. Research indicates that the AIC treatment is safe, does not cause significant side effects, and supports ulcer healing.

The Amnion-Chorion-Amnion (ACA) treatment has also demonstrated promising safety results. In studies with DFUs and VLUs, this treatment has been linked to a good safety record. Patients did not report serious side effects, and the treatment helped ulcers heal more quickly than standard care alone.

These findings suggest that both AIC and ACA treatments are generally safe for treating these types of ulcers. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) because they use innovative placental tissue products. Unlike standard care options that focus on cleaning, debridement, and moisture balance, these treatments incorporate Amnion-Chorion-Amnion (ACA) and Amnion-Intermediate-Chorion (AIC) sheets derived from human placental tissue, which provide a unique biological scaffold that may enhance healing. The potential of these treatments lies in their ability to deliver a complex mix of proteins and growth factors directly to the wound site, potentially accelerating closure and improving outcomes compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for diabetic foot and venous leg ulcers?

This trial will compare the effectiveness of different treatments for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). Participants may receive either Amnion-Intermediate-Chorion (AIC) or Amnion-Chorion-Amnion (ACA) treatments, both utilizing layers of amnion and chorion tissue. Research has shown that these treatments effectively heal DFUs and VLUs. Specifically, studies indicate that for DFUs, these treatments lead to faster healing compared to standard care, with over 90% of wounds remaining closed long-term. For VLUs, similar success has been observed, with some trials reporting up to 75% of difficult-to-heal wounds closing within 12 weeks. These treatments promote quicker wound healing and sustained closure, offering hope for those with chronic ulcers. ^{4 6 7 8 9}

Who Is on the Research Team?

Thomas Serena, MD

Principal Investigator

SerenaGroup, Inc.

Tomas Serena, MD

Principal Investigator

SerenaGroup, Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with type 1 or 2 diabetes who have nonhealing foot or leg ulcers. The ulcers should be of a specific size, not involve exposed tendon or bone, and have persisted for at least 4 weeks despite standard care. Participants must also meet certain blood flow criteria to ensure proper wound healing.

Inclusion Criteria

My foot ulcer is mostly below my ankle.

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

My ulcer is between 0.7 and 5.0 cm2 after cleaning.

Exclusion Criteria

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

Women who are pregnant or considering becoming pregnant within the next 6 months are excluded

A subject with a known sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics is excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly treatment with standard of care and CAMPs 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-Chorion-Amnion
• Amnion-Intermediate-Chorion

Trial Overview The study is testing the effectiveness of multiple CAMPs (Cellular, Acellular and Matrix-Like Products) in combination with Standard of Care versus Standard of Care alone in fully closing diabetic foot and venous leg ulcers.

How Is the Trial Designed?

Group I: AIC for VLUs Experimental Treatment 2 Interventions

Participants with a venous leg ulcer (VLU) will receive treatment with an Amnion-Intermediate-Chorion sheet, a dehydrated multilayer human placental product 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: AIC for DFUs Experimental Treatment 2 Interventions

Participants with a diabetic foot ulcer (DFU) will receive treatment with an Amnion-Intermediate-Chorion 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 III: ACA for VLUs Experimental Treatment 2 Interventions

Participants with a venous leg ulcer (VLU) will receive treatment with an Amnion-Chorion-Amnion allograft sheet, a dehydrated trilayer human placental product 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 IV: ACA for DFUs Experimental Treatment 2 Interventions

Participants with a diabetic foot ulcer (DFU) will receive treatment with an Amnion-Chorion-Amnion sheet allograft product, a dehydrated trilayer 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 V: 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+

SerenaGroup, Inc.

Collaborator

Trials

32

Recruited

3,900+

LifeCell

Industry Sponsor

Trials

21

Recruited

2,500+

Published Research Related to This Trial

In a study of 218 patients with diabetic foot ulcers, treatment with a bioengineered living cellular construct (BLCC) resulted in a significantly faster healing time (median 13.3 weeks) compared to a dehydrated human amnion/chorion membrane allograft (dHACM) which took 26 weeks.

Patients treated with BLCC had a higher healing rate, with 72% healed by 24 weeks compared to 47% for dHACM, indicating that BLCC is nearly twice as effective in promoting healing of diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of a bioengineered living cellular construct vs. a dehydrated human amniotic membrane allograft for the treatment of diabetic foot ulcers in a real world setting. Kirsner, RS., Sabolinski, ML., Parsons, NB., et al.[2022]

In a case series of six patients with chronic lower leg ulcers, the use of dehydrated human amnion/chorion membrane allograft (dHACM) once a week for 5 weeks led to effective pain reduction and improved wound healing in three patients with different ulcer causes.

The study suggests that pain reduction observed after 1 to 2 applications of dHACM can predict a favorable healing response, which may help clinicians decide whether to continue or discontinue treatment, potentially reducing costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain reduction by dehydrated human amnion/chorion membrane allograft in nondiabetic leg ulcers might be an early indicator of good response: A case series. Mueller, SM., Navarini, AA., Itin, P., et al.[2021]

In a study of 21 patients undergoing lower extremity surgery, the use of dehydrated human amnion and chorion allograft (dHACA) significantly improved post-treatment AOFAS scores from 35.8 to 87.5, indicating enhanced overall function and reduced pain.

The application of dHACA was associated with fewer wound complications, including no instances of wound dehiscence, suggesting it may be a beneficial adjunct in foot and ankle surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound repair, safety, and functional outcomes in reconstructive lower extremity foot and ankle surgery using a dehydrated amnion/chorion allograft membrane. Tacktill, JZ., Rasor, Z., Adams, J., et al.[2022]

The study confirmed that PURION® processed dehydrated human amnion/chorion tissue allografts (dHACM) retain significant biological activities, including the presence of various growth factors and interleukins that promote wound healing, as demonstrated through enzyme-linked immunosorbent assays (ELISA).

In both in vitro and in vivo experiments, dHACM was shown to stimulate human dermal fibroblast proliferation and recruit mesenchymal stem cells to the site of implantation, indicating its potential effectiveness in enhancing wound healing through a paracrine mechanism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Koob, TJ., Rennert, R., Zabek, N., et al.[2022]

In a clinical trial involving 110 patients with chronic lower extremity ulcers, those treated with dehydrated human amnion/chorion membrane allograft (dHACM) showed a significantly higher complete healing rate (70% vs. 50%) compared to those receiving standard care over 12 weeks.

Patients receiving dHACM not only healed faster but were also more than twice as likely to achieve complete healing within the study period, indicating its efficacy as a treatment for diabetic ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers: A prospective, multicentre, randomised, controlled study of 110 patients from 14 wound clinics. Tettelbach, W., Cazzell, S., Reyzelman, AM., et al.[2020]

A 22-year-old female trauma patient with severe soft tissue loss and exposed bone successfully received four applications of dehydrated human amnion/chorion membrane (dHACM), which stimulated robust granulation tissue formation over her wounds.

The use of dHACM was crucial in preparing the wounds for skin grafting, ultimately contributing to limb salvage and a positive surgical outcome where traditional methods had failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placenta to the Rescue: Limb Salvage Using Dehydrated Human Amnion/Chorion Membrane. Schlanser, V., Dennis, A., Ivkovic, K., et al.[2020]

In a study of 117 patients treated with dehydrated human amnion/chorion membrane (dHACM) allografts over 2 years, 91.1% achieved complete healing of their nonhealing wounds, demonstrating the efficacy of this treatment.

dHACM was effective for various types of wounds, including diabetic foot ulcers and venous leg ulcers, with an average of 5.1 weekly applications needed for healing, indicating its potential as a versatile option in advanced wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Dehydrated Human Amnion/Chorion Membrane Allografts in More Than 100 Patients with Six Major Types of Refractory Nonhealing Wounds. Garoufalis, M., Nagesh, D., Sanchez, PJ., et al.[2018]

In a randomized controlled trial involving 60 subjects with nonhealing diabetic foot ulcers, dehydrated human amnion and chorion allograft (dHACA) demonstrated a significantly faster healing time compared to the tissue-engineered skin substitute (TESS), with mean healing times of 32 days for dHACA versus 63 days for TESS at 12 weeks.

The dHACA group also showed a higher healing rate of 90% compared to 40% for the TESS group, and it was more cost-effective, with an average cost of $2,200 for dHACA compared to $7,900 for TESS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placental Membrane Provides Improved Healing Efficacy and Lower Cost Versus a Tissue-Engineered Human Skin in the Treatment of Diabetic Foot Ulcerations. Glat, P., Orgill, DP., Galiano, R., et al.[2022]

In a study comparing dehydrated human amnion and chorion allograft (dHACA) to standard care for chronic diabetic foot ulcers, 70% of wounds treated with dHACA healed at 6 weeks, compared to only 15% with standard care.

At 12 weeks, dHACA treatment resulted in 85% healing of wounds, significantly faster than the 25% healing rate in the standard care group, demonstrating its efficacy in promoting wound closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aseptically Processed Placental Membrane Improves Healing of Diabetic Foot Ulcerations: Prospective, Randomized Clinical Trial. DiDomenico, LA., Orgill, DP., Galiano, RD., et al.[2022]

Citations

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

A confirmatory study on the efficacy of dehydrated human ... These results confirm that dHACM is an efficacious treatment for lower extremity ulcers in a heterogeneous patient population.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2213909513000402

Dehydrated human amnion/chorion membrane allografts in ... Treatment with dHACM allografts promotes rapid healing of diabetic ulcers. 94.4% of wounds healed with dHACM remained closed after 9–12 months.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4235421/

A prospective, randomised comparative study of weekly ... Our results show that diabetic ulcers treated with weekly application of dHACM healed in a significantly more rapid fashion than those treated with biweekly ...

4. magonlinelibrary.com magonlinelibrary.com/doi/10.12968/jowc.2024.0139

Dehydrated Amnion Chorion Membrane versus standard of ... In recent real-world data, comparative effectiveness research studies of CAMPs for the treatment of hard-to-heal ulcers, median times to wound ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/iwj.13591

Potential cost‐effectiveness of using adjunctive dehydrated ... The aim of this study was to estimate the cost-effectiveness of using dehydrated human amnion/chorion membrane (dHACM) allografts (Epifix) as an adjunct to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7949511/

A prospective, randomised, multi‐centre clinical trial in 80 ... Amnion and chorion allografts have shown great promise in healing diabetic foot ulcers (DFUs). Results from an interim analysis of 40 patients have ...

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

Human amniotic membrane products for patients with diabetic ... A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers ...

8. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39864&ver=2

Skin Substitute Grafts/Cellular and Tissue-Based Products ... This LCD covers skin substitute grafts/cellular and tissue-based products (CTP) for the treatment of diabetic foot ulcers (DFU) and venous leg ulcers (VLU) in ...

9. tandfonline.com tandfonline.com/doi/full/10.1080/14712598.2020.1787979

Up-to-date role of the dehydrated human amnion/chorion ... Amniofix and other dHACM (dehydrated human amniotic/chorionic membrane) therapies reported faster and complete healing with lower complication rates, when ...