Non-healing WoundNCT05766982
Kerecis Fish Skin Grafts With and Without Platelet Rich Plasma (PRP)
A study testing Platelet Rich Plasma in people with Non-healing Wound, run by St Elizabeth Healthcare at 1 site in United States.
Trial summary
This prospective, randomized pilot study compares the use of a xenograft with PRP to a xenograft alone for chronic, nonhealing wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-healing Wound
- What is being tested?
- Platelet Rich Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is over the age of 18 years;
- The targeted wound is deemed a chronic, nonhealing wound after six weeks of treatment; - - Patient of Dr. Eldridge, Dr. Glenn, or Dr. Worley;
- Target wound size must be between 2 cm x 2 cm x 0.1 cm deep and 10 cm x 10 cm x 5 cm deep;
- Surgical candidate for standard of care Kerecis® xenograft surgery.
Who cannot join
- Patient with hemoglobin values less than 6.9 g/dL drawn at least 30 days prior to the Kerecis® xenograft surgery;
- Patient with a known allergy or other sensitivity to fish material;
- Patient is currently undergoing chemotherapy or radiation therapy;
- The targeted wound is of autoimmune origin; and Non-English-speaking patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Elizabeth Healthcare Edgewood
Edgewood, Kentucky, 41017
About this study
Official title: Fish Skin Grafts With Platelet-rich Plasma Compared to Fish Skin Grafts for Chronic Wound Healing: Randomized, Prospective Trial
This prospective, randomized pilot study compares the use of a xenograft with PRP to a xenograft alone for chronic, nonhealing wounds.
- Conditions
- Non-healing Wound
- Being tested
- Platelet Rich Plasma
- Keywords
- xenograft, PRP, platelet rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaOther
Platelet rich plasma will be applied to assess rate of wound healing.
| Study group | Role | What they receive |
|---|---|---|
| Xenograft only | No intervention | The Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied without the application of PRP. |
| Xenograft and PRP | Experimental | The Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied with the application of PRP. Receives: Other: Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to wound being deemed healed or 6 months
Assessed by time, surface area of wound, wound volume and relative surface size
Measured: 6 months
Secondary outcomes (1)
Wound quality of life
The Wound-QoL-14 questionnaire on quality of life with chronic wounds will be used to assess changes in score prior to initial application of xenograft or xenograft/PRP to time of wound healing or 6 months, whichever comes first.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start30 Jan 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionSep 2025 (estimated)
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-healing WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a 1:1 randomized controlled trial with parallel group assignment.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Elizabeth Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766982
- Sponsor's protocol ID
- ELD.001
- Status last verified
- Jul 2024
- First submitted
- 2 Mar 2023
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fish Skin Grafts With Platelet-rich Plasma Compared to Fish Skin Grafts for Chronic Wound Healing: Randomized, Prospective Trial
- ClinicalTrials.gov ID
- NCT05766982
- Acronym / sponsor ID
- ELD.001
- Conditions
- Non-healing Wound
- Keywords
- xenograft, PRP, platelet rich plasma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St Elizabeth HealthcareUniversity, hospital or other
- Study start
- 30 Jan 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, randomized pilot study compares the use of a xenograft with PRP to a xenograft alone for chronic, nonhealing wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will be a 1:1 randomized controlled trial with parallel group assignment.
| Arm | Type | Receives |
|---|---|---|
| Xenograft only | No intervention | –The Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied without the application of PRP. |
| Xenograft and PRP | Experimental | Other: Platelet Rich PlasmaThe Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied with the application of PRP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is over the age of 18 years;
- The targeted wound is deemed a chronic, nonhealing wound after six weeks of treatment; - - Patient of Dr. Eldridge, Dr. Glenn, or Dr. Worley;
- Target wound size must be between 2 cm x 2 cm x 0.1 cm deep and 10 cm x 10 cm x 5 cm deep;
- Surgical candidate for standard of care Kerecis® xenograft surgery.
Key exclusion criteria (4 listed)
- Patient with hemoglobin values less than 6.9 g/dL drawn at least 30 days prior to the Kerecis® xenograft surgery;
- Patient with a known allergy or other sensitivity to fish material;
- Patient is currently undergoing chemotherapy or radiation therapy;
- The targeted wound is of autoimmune origin; and Non-English-speaking patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Rich PlasmaPlatelet rich plasma will be applied to assess rate of wound healing. | Other | Xenograft and PRP |
Primary outcome
Time to wound being deemed healed or 6 months
Time frame: 6 months
Assessed by time, surface area of wound, wound volume and relative surface size
1 secondary outcome
Wound quality of life
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Plasma in people with Non-healing Wound, run by St Elizabeth Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to wound being deemed healed or 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.