PalinGen Flow Amniotic Tissue Allograft for Chronic Leg Ulcer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Chronic Leg UlcerPalinGen Flow Amniotic Tissue Allograft - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new treatment for chronic ulcers of the lower legs and feet to see if it is safe and effective.

Eligible Conditions
  • Chronic Leg Ulcer

Treatment Effectiveness

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: All adverse events (AEs) and serious adverse events (SAEs) will be recorded from the time of signing of the informed consent form through Week 64.

Week 64
Proportion of participants in the PalinGen Flow plus SOC group versus SOC alone with treatment-emergent adverse events (TEAEs)
Week 12
Proportion of participants in the PalinGen Flow plus SOC group versus SOC alone who achieve complete ulcer closure by Week 12.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Standard of Care (SOC)
1 of 2
PalinGen Flow Treatment plus SOC
1 of 2

Active Control

Experimental Treatment

81 Total Participants · 2 Treatment Groups

Primary Treatment: PalinGen Flow Amniotic Tissue Allograft · No Placebo Group · Phase 2

PalinGen Flow Treatment plus SOC
Biological
Experimental Group · 1 Intervention: PalinGen Flow Amniotic Tissue Allograft · Intervention Types: Biological
Standard of Care (SOC)NoIntervention Group · 1 Intervention: Standard of Care (SOC) · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: all adverse events (aes) and serious adverse events (saes) will be recorded from the time of signing of the informed consent form through week 64.

Who is running the clinical trial?

Amnio Technology, LLCLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Extends through the full thickness of the skin but doesn't go down to muscle, tendon, or bone.
The patient has been unresponsive to standard of care treatment for at least four weeks.
and no purulent drainage or exudate A person has an ulcer area that is ≥1.5 cm2 and ≤20 cm2
They can read, understand, and sign the ICF.
I am available and willing to complete all study assessments.
, ambulation or use of lower extremity extremity aids with greater then 0 weight-bearing is allowed Patients are allowed to ambulate or use lower extremity aids with greater than 0 weight-bearing at least 12 weeks post-revascularization procedure.
You have diabetes mellitus or vascular disease.
You have a total area of ≤ 20 cm2.
Ulcer location is at or above the ankle (malleolus) and below the knee.
If you have an ulcer on your leg, compression therapy treatment can help to heal it