CompletedNot Applicable

The RESPOND Registry

United States310 participantsStarted 2017-02-21

Plain-language summary

The RESPOND Registry is an observational study to assess the impact of PuraPly™ AM on the management of wounds in real world clinical settings; no experimental intervention is involved.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient is at least 18 years of age. * Patient, or their legally authorized representative (LAR), has read, understood and signed and Institutional Review Board (IRB) approved Informed Consent Form (ICF). * Patient has a wound appropriate for receiving PuraPly™ AM, including: * Partial or full-thickness wound * Pressure ulcer * Venous ulcer * Diabetic ulcer * Chronic vascular ulcer * Tunneled/undermined wound * Surgical wound (e.g., donor sites/graft, post-Mohs' surgery, post-laser surgery, podiatric surgery wound, wound dehiscence) * Trauma wound (abrasions, lacerations, second degree burns, and skin tears) * Draining wound Exclusion Criteria: * Patient has a known sensitivity to porcine materials. * Patient has a third-degree burn. * Patient has a known sensitivity to polyhexamethylenebiguanide hydrochloride (PHMB). * Patient's target wound was previously treated with PuraPly™ AM.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction in size of wound area

Timeframe: Up to 24 weeks

Time to complete wound closure

Timeframe: Up to 24 weeks

Improvement in wound bed condition

Timeframe: Up to 24 weeks

Trial details

NCT IDNCT03286452

SponsorOrganogenesis

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-07-15

View on ClinicalTrials.gov More Partial Thickness Wound trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.