170 Participants Needed

PuraPly AM for Diabetic Foot Ulcers

(PREPARE Trial)

BM
MB
Overseen ByMeghan Byrd
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This prospective, multi-center, randomized, controlled modified platform Trial compares Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care versus Standard of Care Alone in subjects with chronic DFUs.

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 participate if you are taking immunosuppressants, cytotoxic chemotherapy, or hydroxyurea, as these may interfere with wound healing.

What data supports the effectiveness of the treatment PuraPly AM for Diabetic Foot Ulcers?

Research shows that using a collagen-rich hydrogel, similar to the components in PuraPly AM, can effectively inhibit bacterial growth and promote healing in chronic wounds. Additionally, studies on other collagen-based treatments have demonstrated improved healing rates in diabetic foot ulcers compared to standard care.12345

Is PuraPly AM safe for use in humans?

The studies on PCMP, which is similar to PuraPly AM, focus on its effectiveness in treating various wounds, but they do not specifically mention any safety concerns, suggesting it is generally considered safe for use in humans.678910

What makes the PuraPly AM treatment unique for diabetic foot ulcers?

PuraPly AM is unique because it combines a purified collagen matrix with an antimicrobial agent, polyhexamethylene biguanide, which helps to both support wound healing and prevent infection, unlike standard treatments that may not offer both benefits simultaneously.15111213

Research Team

MH

Maribel Henao

Principal Investigator

Organogenesis

Eligibility Criteria

This trial is for people with chronic diabetic foot ulcers (DFUs) that haven't healed. Participants should be adults who can follow the study procedures and visit schedules. Those with infected wounds, allergies to collagen or antimicrobial agents used in the study, or other health conditions that could interfere with wound healing are not eligible.

Inclusion Criteria

My foot ulcer is mostly below my ankle.
My ulcer has been present for at least 4 weeks.
I have more than one ulcer, and they are at least 2 cm apart.
See 8 more

Exclusion Criteria

The potential subject is known to have a life expectancy of < 6 months
My ulcer exposes tendon or bone.
I am taking antibiotics for an infection in my ulcer or elsewhere.
See 15 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization

Participants are randomized into different treatment groups

1 week

Treatment

Participants receive weekly treatment with either PuraPly AM + SOC, PuraPly XT + SOC, or SOC alone

12 weeks
12 visits (in-person)

Healing Confirmation

A visit to confirm maintenance of complete wound closure for subjects that heal

2 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP)
Trial Overview The trial is testing if adding a product called PuraPly AM (which contains purified collagen and an antimicrobial agent) to standard ulcer care helps heal foot ulcers better than just standard care alone. It's a controlled test where patients are randomly chosen to receive either the new treatment plus standard care or only standard care.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Standard of CareExperimental Treatment1 Intervention
Standard of Care (SOC)
Group II: PuraPly AM + SOCActive Control2 Interventions
PuraPly Antimicrobial Wound Matrix along with standard of care
Group III: PuraPly XT + SOCActive Control2 Interventions
PuraPly Antimicrobial XT Wound Matrix along with standard of care

Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP) is already approved in United States for the following indications:

🇺🇸
Approved in United States as PCMP for:
  • Management of Nonhealing Diabetic Foot Ulcers

Find a Clinic Near You

Who Is Running the Clinical Trial?

Organogenesis

Lead Sponsor

Trials
37
Recruited
4,400+

Serena Group

Collaborator

Trials
6
Recruited
790+

Serena Group

Collaborator

Trials
6
Recruited
790+

Findings from Research

In a clinical trial involving 226 patients with hard-to-heal diabetic foot ulcers, the use of fetal bovine acellular dermal matrix (FBADM) alongside standard care resulted in a significantly higher rate of complete wound closure compared to standard care alone (45.6% vs. 27.9%).
FBADM treatment was found to be safe, with no serious adverse events related to the product, and it often achieved wound closure faster, with a median time of 43 days compared to 57 days for standard care.
Fetal bovine acellular dermal matrix for the closure of diabetic foot ulcers: a prospective randomised controlled trial.Lantis, JC., Snyder, R., Reyzelman, AM., et al.[2022]
A novel collagen-rich hydrogel derived from human extracellular matrix can effectively deliver antibiotics to chronic wounds, providing sustained release for up to 24 hours while promoting healing and neovascularization.
The hydrogel successfully inhibited bacterial growth and disrupted biofilm formation without causing cytotoxicity to mammalian cells, making it a promising treatment option for chronic wounds.
Topical Antibiotic Elution in a Collagen-Rich Hydrogel Successfully Inhibits Bacterial Growth and Biofilm Formation In Vitro.Min, JG., Sanchez Rangel, UJ., Franklin, A., et al.[2021]
In a study of 105 diabetic patients with foot ulcers, the use of a collagen bilayer matrix (Integra) showed promise for limb salvage, particularly in patients at low risk for amputation, where only 17% progressed to amputation.
However, in patients identified as high risk for amputation, the collagen matrix did not significantly improve limb salvage rates, with 54% still progressing to amputation, indicating that underlying conditions like poor blood supply and infection heavily influence outcomes.
Functional limb salvage in the diabetic patient: the use of a collagen bilayer matrix and risk factors for amputation.Iorio, ML., Goldstein, J., Adams, M., et al.[2022]

References

Fetal bovine acellular dermal matrix for the closure of diabetic foot ulcers: a prospective randomised controlled trial. [2022]
Topical Antibiotic Elution in a Collagen-Rich Hydrogel Successfully Inhibits Bacterial Growth and Biofilm Formation In Vitro. [2021]
Functional limb salvage in the diabetic patient: the use of a collagen bilayer matrix and risk factors for amputation. [2022]
A Feasibility and Safety Study of a Novel Human Decellularized Dermal Matrix to Accelerate Healing of Neuropathic Diabetic Foot Ulcers in People With Type 1 and Type 2 Diabetes. [2022]
A multi-centre, single-blinded randomised controlled clinical trial evaluating the effect of resorbable glass fibre matrix in the treatment of diabetic foot ulcers. [2022]
Type I collagen matrix plus polyhexamethylene biguanide antimicrobial for the treatment of cutaneous wounds. [2021]
Use of Native Type I Collagen Matrix Plus Polyhexamethylene Biguanide for Chronic Wound Treatment. [2022]
Effectiveness of type I collagen matrix plus polyhexamethylene biguanide antimicrobial for the treatment of pressure injuries. [2023]
Effect of Native Type I Collagen with Polyhexamethylene Biguanide Antimicrobial on Wounds: Interim Registry Results. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
A Prospective Noninterventional Study of Type I Collagen Matrix Plus Polyhexamethylene Biguanide Antimicrobial for the Treatment of Venous Leg Ulcers: A Secondary Analysis. [2022]
Porcine urinary bladder matrix: a retrospective study and establishment of protocol. [2012]
12.United Statespubmed.ncbi.nlm.nih.gov
Collagenase-labile polyurethane urea synthesis and processing into hollow fiber membranes. [2014]
Application of a collagen matrix dressing on a neuropathic diabetic foot ulcer: a randomised control trial. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security