An interventional study of Standard of Care and PuraPly AM in Diabetic Foot Ulcer, sponsored by Organogenesis. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Organogenesis · Not applicable, Interventional, and Treatment
Among 381 studies in Diabetic Foot with a site in United States — 67 open to participants now, 86 under way, 3 of them phase 3. Diabetic Foot · United States.
Among the 381 studies in Diabetic Foot with a site in United States, this one is the 63rd largest by planned enrollment of the 322 interventional ones that give a count, is one of 33 that started in 2024, is one of 186 with no phase, reaches primary completion later than 33 of the 85 other live ones, and was the 335th registered.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
Browse Diabetic Foot studies →67 of the 381 studies in Diabetic Foot with a site in United States are open now. Recruiting first, the newest first:
Applied Biologics, LLC · Sites in United States
Ages 18+
Biodynamik, Inc · Sites in United States
Ages 22+
Lakewood-Amedex Inc · Sites in United States
Ages 18+
Capsicure, LLC · Sites in United States
Ages 18+
Reprise Biomedical, Inc. · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 137 Diabetic Foot studies recruiting now, 96 (70%) set no upper age limit and 12 (9%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
381 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 54 · Phase 3 37 · Phase 4 31
First in 1994; this study’s year is marked. 33 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 170 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Median enrollment 60 across the 322 interventional studies, 138 across the 58 observational. Of the 247 that completed or were terminated, 89 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
253 of 381 have an industry lead sponsor. The 10 most frequent:
Organogenesis is the lead sponsor of 27 studies on the registry; 2 are open to participants now.
Organogenesis has 8 studies filed under Diabetic Foot — fewer than ten, so there is no comparison to draw.
33 of the studies in Diabetic Foot with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05369052Phase 3MicuRxSafety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI) | 2027-06-30 |
| NCT07852338Phase 3Applied Biologics, LLCa Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers | 2027-09 |
| NCT06420245Legacy Medical ConsultantsClinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management | 2026-11 |
| NCT06449638StimLabsModified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs | 2026-11 |
| NCT06681428Tides MedicalRising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers | 2026-11-18 |
Add all 33 to your calendar (.ics) → With an account.
Among the 381 studies in Diabetic Foot with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
At least 170 subjects with a chronic DFU will be randomized 1.4:1:1 to the SOC group, PuraPly AM + SOC, or PuraPly XT + SOC.
Following screening and randomization, subjects shall be seen weekly for up to 12 weeks. For subjects that heal, a healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard of Care (SOC)
Other: Standard of Care
PuraPly Antimicrobial Wound Matrix along with standard of care
Other: Standard of Care · Device: PuraPly AM
PuraPly Antimicrobial XT Wound Matrix along with standard of care
Other: Standard of Care · Device: PuraPly XT
Standard of Care (SOC) includes, but is not limited to, surgical debridement, aggressive infection management, offloading, and maintenance of appropriate cleansing at the time of each dressing change.
PuraPly Antimicrobial Wound Matrix is a 2-layer cross-linked extracellular matrix (PCMP) scaffolding that consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB)
PuraPly Antimicrobial XT Wound Matrix is a 5- layer cross-linked extracellular matrix (PCMP) scaffolding that consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB)
Determine the efficacy of multiple Polyhexamethylene Biguanide Antimicrobial (PCMPs) plus SOC versus SOC alone in achieving complete closure
The percentage of target ulcers achieving complete wound closure in 12 weeks
Time frame: 12 weeks
Time to closure for the target ulcer.
Time frame: 12 weeks
Percentage wound area reduction from Treatment Visit-1 to Treatment Visit-13
Time frame: 12 weeks
The number of adverse events.
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Aug 2026, 24 months after the start.
Of 103 industry-sponsored interventional studies with no phase under Diabetic Foot, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 24 months is close to that.
Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.