Amniotic Fluid Therapy for Leg Ulcers

Recruiting at 8 trial locations

Overseen By T Che Jarrell, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merakris Therapeutics

Must not be taking: Topical antimicrobials, Corticosteroids

Disqualifiers: PAD, CHF, Osteomyelitis, DVT, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

DL-VSU-201 is a randomized, double-blind, placebo controlled study in subjects with a non-infected venous stasis ulcer (VSU) that has failed to demonstrate improvement after receiving at least 4 weeks of standard, conventional wound therapy to evaluate the efficacy and safety of Dermacyte® Liquid (MTX-001).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on certain treatments like topical antimicrobials, corticosteroids, or skin graft substitutes close to the start of the trial. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Dermacyte® Liquid, Dermacyte Amniotic Wound Care Liquid, MTX-001 for leg ulcers?

Research shows that amniotic membrane, a component of the treatment, can help heal stubborn leg ulcers by promoting skin growth and reducing inflammation. Studies have found that using amniotic membrane in patients with difficult-to-heal leg ulcers led to significant healing and was well-tolerated by patients. ^{1 2 3 4 5}

How is the treatment Dermacyte® Liquid unique for leg ulcers?

Dermacyte® Liquid, which uses amniotic fluid, is unique because it promotes healing by providing growth factors and reducing inflammation, unlike standard treatments that may not address these aspects. This approach is particularly beneficial for ulcers that do not heal with conventional methods. ^{1 3 5 6 7}

Eligibility Criteria

This trial is for adults aged 18-75 with non-healing venous stasis ulcers who've tried standard treatments without improvement. Participants must have had prior vein treatment, stable ulcer size, good blood flow in the affected leg, and an ulcer between 1 cm2 and 25 cm2. Exclusions include active skin grafts or regenerative therapies within the last month, infected ulcers, nearby additional ulcers, exposed bone at the ulcer site, limited mobility due to chronic conditions, or use of systemic corticosteroids.

Inclusion Criteria

I have been on standard treatment for more than 28 days before my first visit.

My ulcer size has been stable for the last 2 weeks.

My leg ulcer is due to poor vein function confirmed by a recent ultrasound.

Exclusion Criteria

I haven't had any skin graft substitutes or regenerative therapies in the last 30 days.

I am not using any skin infection creams and my wound does not look or smell infected.

I do not have another ulcer within 3 cm of the one being treated.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Run-in Phase

Part 1 of the study where 10 subjects are randomized to receive active Dermacyte once weekly or once every two weeks with standard of care

4 weeks

Weekly visits (in-person)

Treatment

Part 2 of the study where subjects receive Dermacyte Liquid or placebo with standard of care, assessed for safety and efficacy

12 weeks

Visits at Baseline, Weeks 4, 8, and 12 (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dermacyte® Liquid

Trial Overview The study tests Dermacyte® Liquid (human amniotic fluid) on leg ulcers that haven't healed with usual care. It's a randomized trial where patients are blindly assigned to receive either Dermacyte® Liquid or a placebo to assess effectiveness and safety.

Participant Groups

Group I: Dermacyte® Liquid (human amniotic fluid) Active Control 1 Intervention

Dermacyte® Liquid (human amniotic fluid) solution 1.0mL to 2.0mL weekly

Group II: Placebo (0.9% saline) Placebo Group 1 Intervention

Matching placebo solution 1.0mL to 2.0mL weekly

Dermacyte® Liquid is already approved in United States for the following indications:

Approved in United States as Dermacyte Liquid for:

• Non-healing venous stasis ulcers (VSUs)

Who Is Running the Clinical Trial?

Merakris Therapeutics

Lead Sponsor

Trials

3

Recruited

140+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

Findings from Research

A patient with chronic, non-healing venous ulcers, who did not respond to standard treatments, showed improvement after receiving a combination of cell-free amniotic fluid and dehydrated amniotic membrane following thermal ablation of incompetent veins.

This case highlights the potential of using advanced biological treatments to enhance wound healing in patients with persistent venous ulcers, suggesting a new avenue for managing these challenging conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of acellular human amniotic fluid and membrane in the treatment of non-healing wounds in a patient with chronic venous insufficiency. Ditmars, FS., Lind, RA., Broderick, TC., et al.[2022]

The amniotic membrane shows promise as a biological dressing for treating chronic venous ulcers that do not respond to standard antiseptics and dressings, potentially due to its antiseptic and immunomodulatory properties.

This approach could offer a new therapeutic option for patients with persistent ulcers, addressing a common and challenging health issue in the population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Amniotic Membrane as a Biological Dressing for the Treatment of Torpid Venous Ulcers: A Case Report. Alonso-Carpio, M., Sánchez-García, A., Trapero, A., et al.[2021]

In a pilot study involving 13 patients with chronic varicose leg ulcers that did not respond to standard treatments, the use of amniotic membrane (AM) showed effectiveness in promoting healing and epithelization.

After 2 years, only 23% of the patients experienced a recurrence of their ulcers, suggesting that AM can be a viable treatment option for patients with refractory ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amniotic Membrane in the Treatment of Varicose Ulcers: a Center Experience. Rocha-Neves, J., Ferreria, A., Sousa, J., et al.[2019]

In a study of 84 patients with chronic ulcer wounds, liquid wound dressing was found to be significantly more effective than iodophor, achieving a 100% effective rate compared to 85% in the control group.

The liquid wound dressing not only improved wound healing rates and reduced healing time but also decreased the frequency of dressing changes, indicating a more efficient treatment approach for chronic ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[CLINICAL APPLICATION OF LIQUID WOUND DRESSING IN TREATMENT OF CHRONIC ULCER WOUNDS]. Wang, C., Li, T., Luo, P., et al.[2018]

In a study of 40 patients with resistant nonhealing venous leg ulcers, a single transfer of amniotic membrane (AM) significantly promoted healing, with over 75% of the ulcer area healing in many cases during a follow-up period of up to 3 years.

The treatment was found to be safe, inexpensive, and well-accepted by patients, showing promise as an effective option for chronic venous leg ulcers that have not responded to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Amnion Transfer in Resistant Nonhealing Venous Leg Ulcers. Francis, J., Shajimon, CR., Bhat, AK., et al.[2018]

In a study involving 15 patients with chronic leg ulcers, those treated with human amniotic membrane dressings healed more rapidly compared to those treated with standard dressings, indicating the efficacy of this treatment.

All ulcers treated with human amnion became pain-free quickly, highlighting not only the healing benefits but also the potential for improved patient comfort during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human amnion in the treatment of chronic ulceration of the legs. Shun, A., Ramsey-Stewart, G.[2021]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of acellular human amniotic fluid and membrane in the treatment of non-healing wounds in a patient with chronic venous insufficiency. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Use of Amniotic Membrane as a Biological Dressing for the Treatment of Torpid Venous Ulcers: A Case Report. [2021]

3. Portugal pubmed.ncbi.nlm.nih.gov

Amniotic Membrane in the Treatment of Varicose Ulcers: a Center Experience. [2019]

4. China pubmed.ncbi.nlm.nih.gov

[CLINICAL APPLICATION OF LIQUID WOUND DRESSING IN TREATMENT OF CHRONIC ULCER WOUNDS]. [2018]

5. India pubmed.ncbi.nlm.nih.gov

Use of Amnion Transfer in Resistant Nonhealing Venous Leg Ulcers. [2018]

6. Australia pubmed.ncbi.nlm.nih.gov

Human amnion in the treatment of chronic ulceration of the legs. [2021]

7. United States 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. [2021]