Clinical trial NCT03997526: 3C Patch® Medicare Claims Study
Official title: Reapplix 3C Patch® System for the Treatment of Diabetic Foot Ulcers: A Medicare Claims Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetic Foot Ulcer
Keywords: 3C Patch
Reapplix
LeucoPatch
Lead sponsor: Reapplix
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Medicare beneficiaries diagnosed with diabetic foot ulcer

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Complete healing
timeFrame: within 20 weeks of the first application of the 3C Patch.
Secondary outcomes:
measure: Number of 3C Patch® treatments administered
timeFrame: 20 weeks
measure: Major amputation - target limb
timeFrame: 24 weeks
measure: Major amputation - contralateral limb
timeFrame: 24 weeks
measure: Minor amputation - target limb
timeFrame: 24 weeks
measure: Minor amputation - contralateral limb
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Natchitoches
country: United States
facility: Natchitoches Regional Medical Center
state: Louisiana
city: Opelousas
country: United States
facility: Opelousas General Hospital Wound Center
state: Louisiana
city: Cape Girardeau
country: United States
facility: Southeast Wound Care and Hyperbaric Medical Center
state: Missouri
city: Poplar Bluff
country: United States
facility: Regional One Physician Specialists
state: Missouri
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
Study officials:
References:
citation: 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.
citation: Londahl 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.