Diabetic Foot UlcerNCT03997526
3C Patch® Medicare Claims Study
An observational study of Diabetic Foot Ulcer, run by Reapplix at 6 sites in United States.
Trial summary
This prospective study will compare incidence rates of complete hard-to-heal diabetic foot ulcer healing in Medicare beneficiaries following application of the 3C Patch® plus usual care, tested against a historical control group of similar patients that received usual care during a randomized controlled trial. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- 3C Patch
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Jul 2020to 21 Feb 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Medicare beneficiaries diagnosed with diabetic foot ulcer
Who may be able to join
- Medicare beneficiaries diagnosed with diabetic foot ulcer and receiving at least one treatment with the 3C Patch® System.
- Eligible ulcers will be hard-to-heal, meaning that the cross-sectional area will decrease by less than 50% during a four week period prior to the first application of the 3C Patch® (percentage change in cross-sectional area determined clinically by the treating physician by estimation at examination).
- Eligible ulcer's cross-sectional area will increase by less than 25% during a 4-week period prior to the first application of the 3C Patch® (percentage change determined clinically by treating physician by estimation at examination)
- The cross-sectional area of the index ulcer will be ≥50 and ≤1000 mm2 at the end of the 4 week period prior to the first application of the 3C Patch® (size determined clinically by the treating physician by estimation at examination).
- Participants will have the capacity to understand study procedures, and will be able to provide written informed consent.
Who cannot join
- Presence of sickle-cell anemia, hemophilia, thrombocytopenia (<100x109/L) or other clinically significant blood dyscrasia
- Known potential infectivity of blood products, including known HIV and hepatitis
- Patient in dialysis
- Clinical signs of infection of the index ulcer or reason to suspect that infection is present
- Revascularization procedure in the affected limb planned, or undertaken within the 4 weeks prior to the first application of the 3C Patch®
- Current treatment with cytotoxic drugs or with systemically administered glucocorticoids or other immunosuppressants
Show all 12Show fewer
- Treatment of foot ulcers with growth factors, stem cells or equivalent preparation within the 8 weeks prior to the first application of the 3C Patch®
- The need for continued use of negative pressure wound therapy
- Likely inability to comply with the need for follow up visits because of planned activity
- Participation in another interventional clinical foot ulcer-healing trial within the 4 weeks prior to the first application of the 3C Patch®
- Prior enrollment in this study
- Judgement by the investigator that the patient does not have the capacity to understand the study procedures or provide written informed consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Southeast Wound Care and Hyperbaric Medical Center
Cape Girardeau, Missouri, 63703
UNC Chapel Hill
Chapel Hill, North Carolina, 27514
Natchitoches Regional Medical Center
Natchitoches, Louisiana, 27514
Opelousas General Hospital Wound Center
Opelousas, Louisiana, 70570
Mayo Clinic
Phoenix, Arizona, 84054
Regional One Physician Specialists
Poplar Bluff, Missouri, 63901
About this study
Official title: Reapplix 3C Patch® System for the Treatment of Diabetic Foot Ulcers: A Medicare Claims Study
This prospective study will compare incidence rates of complete hard-to-heal diabetic foot ulcer healing in Medicare beneficiaries following application of the 3C Patch® plus usual care, tested against a historical control group of similar patients that received usual care during a randomized controlled trial.
Read the detailed description
This is a prospective, observational, longitudinal, claims-based study with a historical control group. Data will be collected via claim forms and will be extracted directly from the Centers for Medicare \& Medicaid Services (CMS) Medicare Research Identifiable Files (RIFs), which contain all medical claims for 100% of Medicare beneficiaries enrolled in the Medicare fee-for-service program. The study will be conducted in accordance with relevant guidelines of a central institutional review board (IRB), relevant informed consent regulations, and all other applicable regulatory requirements.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- 3C Patch
- Keywords
- 3C Patch, Reapplix, LeucoPatch
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3C PatchDevice
A platelet-rich plasma gel patch comprised of distinct fibrin, platelet, and leukocyte substantially parallel layers, prepared without the use of any added reagents through a two-step centrifugation process
| Study group | Role | What they receive |
|---|---|---|
| 3C Patch treatment | Medicare beneficiaries with diabetes and hard-to-heal non-healing ulcers of the foot will receive usual care (i.e., care consistent with the IWGDF guidance on use of interventions to enhance the healing of chronic ulcers of the foot in diabetes) supplemented by the application of the 3C Patch (A platelet-rich plasma gel patch comprised of distinct fibrin, platelet, and leukocyte substantially parallel layers, prepared without the use of any added reagents through a two-step centrifugation process) Receives: Device: 3C Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete healing
Rate (%) of complete healing of hard-to-heal diabetic foot ulcers in Medicare beneficiaries following application of the 3C Patch®.
Measured: within 20 weeks of the first application of the 3C Patch.
Secondary outcomes (5)
Number of 3C Patch® treatments administered
The number of 3C Patch® treatments administered within 20 weeks of initial application of the 3C Patch®.
Measured: 20 weeks
Major amputation - target limb
The incidence of major (above ankle) amputation affecting the target limb by 24 weeks
Measured: 24 weeks
Major amputation - contralateral limb
The incidence of major amputation affecting the contralateral limb by 24 weeks
Measured: 24 weeks
Minor amputation - target limb
The incidence of minor (below ankle) amputation affecting the target limb by 24 weeks
Measured: 24 weeks
Minor amputation - contralateral limb
The incidence of minor amputation affecting the contralateral limb by 24 weeks
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start15 Jul 2020
- Primary completion21 Feb 2022
- Study completion21 Feb 2022
Why it stopped: CMS status changed - 3C Patch is now fully covered (NCD) - Medicare will no longer be collecting claims under CED
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reapplix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997526
- Sponsor's protocol ID
- REAPCEDUS01
- Status last verified
- Feb 2022
- First submitted
- 21 Jun 2019
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Game F, Jeffcoate W, Tarnow L, Jacobsen JL, Whitham DJ, Harrison EF, Ellender SJ, Fitzsimmons D, Londahl M; LeucoPatch II trial team. LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked, randomised controlled trial. Lancet Diabetes Endocrinol. 2018 Nov;6(11):870-878. doi: 10.1016/S2213-8587(18)30240-7. Epub 2018 Sep 19.
PubMed 30243803Londahl M, Tarnow L, Karlsmark T, Lundquist R, Nielsen AM, Michelsen M, Nilsson A, Zakrzewski M, Jorgensen B. Use of an autologous leucocyte and platelet-rich fibrin patch on hard-to-heal DFUs: a pilot study. J Wound Care. 2015 Apr;24(4):172-4, 176-8. doi: 10.12968/jowc.2015.24.4.172.
PubMed 25853474
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reapplix 3C Patch® System for the Treatment of Diabetic Foot Ulcers: A Medicare Claims Study
- ClinicalTrials.gov ID
- NCT03997526
- Acronym / sponsor ID
- REAPCEDUS01
- Conditions
- Diabetic Foot Ulcer
- Keywords
- 3C Patch, Reapplix, LeucoPatch
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: CMS status changed - 3C Patch is now fully covered (NCD) - Medicare will no longer be collecting claims under CED
- Enrolment
- 22 participants (actual)
- Lead sponsor
- ReapplixUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 21 Feb 2022 (actual)
- First posted
- 25 Jun 2019 (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 study will compare incidence rates of complete hard-to-heal diabetic foot ulcer healing in Medicare beneficiaries following application of the 3C Patch® plus usual care, tested against a historical control group of similar patients that received usual care during a randomized controlled trial.
Detailed description
This is a prospective, observational, longitudinal, claims-based study with a historical control group. Data will be collected via claim forms and will be extracted directly from the Centers for Medicare \& Medicaid Services (CMS) Medicare Research Identifiable Files (RIFs), which contain all medical claims for 100% of Medicare beneficiaries enrolled in the Medicare fee-for-service program. The study will be conducted in accordance with relevant guidelines of a central institutional review board (IRB), relevant informed consent regulations, and all other applicable regulatory requirements.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3C Patch treatment | – | Device: 3C PatchMedicare beneficiaries with diabetes and hard-to-heal non-healing ulcers of the foot will receive usual care (i.e., care consistent with the IWGDF guidance on use of interventions to enhance the healing of chronic ulcers of the foot in diabetes) supplemented by the application of the 3C Patch (A platelet-rich plasma gel patch comprised of distinct fibrin, platelet, and leukocyte substantially parallel layers, prepared without the use of any added reagents through a two-step centrifugation process) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Medicare beneficiaries diagnosed with diabetic foot ulcer
Key inclusion criteria (5 listed)
- Medicare beneficiaries diagnosed with diabetic foot ulcer and receiving at least one treatment with the 3C Patch® System.
- Eligible ulcers will be hard-to-heal, meaning that the cross-sectional area will decrease by less than 50% during a four week period prior to the first application of the 3C Patch® (percentage change in cross-sectional area determined clinically by the treating physician by estimation at examination).
- Eligible ulcer's cross-sectional area will increase by less than 25% during a 4-week period prior to the first application of the 3C Patch® (percentage change determined clinically by treating physician by estimation at examination)
- The cross-sectional area of the index ulcer will be ≥50 and ≤1000 mm2 at the end of the 4 week period prior to the first application of the 3C Patch® (size determined clinically by the treating physician by estimation at examination).
- Participants will have the capacity to understand study procedures, and will be able to provide written informed consent.
Key exclusion criteria (12 listed)
- Presence of sickle-cell anemia, hemophilia, thrombocytopenia (<100x109/L) or other clinically significant blood dyscrasia
- Known potential infectivity of blood products, including known HIV and hepatitis
- Patient in dialysis
- Clinical signs of infection of the index ulcer or reason to suspect that infection is present
- Revascularization procedure in the affected limb planned, or undertaken within the 4 weeks prior to the first application of the 3C Patch®
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 |
|---|---|---|
| 3C PatchA platelet-rich plasma gel patch comprised of distinct fibrin, platelet, and leukocyte substantially parallel layers, prepared without the use of any added reagents through a two-step centrifugation process | Device | 3C Patch treatment |
Primary outcome
Complete healing
Time frame: within 20 weeks of the first application of the 3C Patch.
Rate (%) of complete healing of hard-to-heal diabetic foot ulcers in Medicare beneficiaries following application of the 3C Patch®.
5 secondary outcomes
Number of 3C Patch® treatments administered
Time frame: 20 weeks
Major amputation - target limb
Time frame: 24 weeks
Major amputation - contralateral limb
Time frame: 24 weeks
Minor amputation - target limb
Time frame: 24 weeks
Minor amputation - contralateral limb
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: CMS status changed - 3C Patch is now fully covered (NCD) - Medicare will no longer be collecting claims under CED). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Background: PubMed 30243803Game F, Jeffcoate W, Tarnow L, Jacobsen JL, Whitham DJ, Harrison EF, Ellender SJ, Fitzsimmons D, Londahl M; LeucoPatch II trial team. LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked, randomised controlled trial. Lancet Diabetes Endocrinol. 2018 Nov;6(11):870-878. doi: 10.1016/S2213-8587(18)30240-7. Epub 2018 Sep 19.
- Background: PubMed 25853474Londahl M, Tarnow L, Karlsmark T, Lundquist R, Nielsen AM, Michelsen M, Nilsson A, Zakrzewski M, Jorgensen B. Use of an autologous leucocyte and platelet-rich fibrin patch on hard-to-heal DFUs: a pilot study. J Wound Care. 2015 Apr;24(4):172-4, 176-8. doi: 10.12968/jowc.2015.24.4.172.
- Individual participant dataSharing planned: No
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer, run by Reapplix at 6 sites 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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 stopped early (reason given: CMS status changed - 3C Patch is now fully covered (NCD) - Medicare will no longer be collecting claims under CED). Results are not available in the source record.
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?
Complete healing (time frame: within 20 weeks of the first application of the 3C Patch.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03997526, which also lists 2 linked publications.
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 9 Mar 2022; AzTrials last refreshed its copy on 29 Oct 2026.