3C Patch® Medicare Claims Study

Diabetic Foot Ulcer Clinical Trial

Official title:

Reapplix 3C Patch® System for the Treatment of Diabetic Foot Ulcers: A Medicare Claims Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03997526
• Other study ID #: REAPCEDUS01
• Status: Terminated
• Start date: July 15, 2020
• Est. completion date: February 21, 2022

Study information

• Verified date: February 2022
• Source: Reapplix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: February 21, 2022
• Est. primary completion date: February 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Southeast Wound Care and Hyperbaric Medical Center	Cape Girardeau	Missouri
United States	UNC Chapel Hill	Chapel Hill	North Carolina
United States	Natchitoches Regional Medical Center	Natchitoches	Louisiana
United States	Opelousas General Hospital Wound Center	Opelousas	Louisiana
United States	Mayo Clinic	Phoenix	Arizona
United States	Regional One Physician Specialists	Poplar Bluff	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Reapplix

Country where clinical trial is conducted

United States, 

References & Publications (2)

Game F, Jeffcoate W, Tarnow L, Jacobsen JL, Whitham DJ, Harrison EF, Ellender SJ, Fitzsimmons D, Löndahl 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. — View Citation

Löndahl M, Tarnow L, Karlsmark T, Lundquist R, Nielsen AM, Michelsen M, Nilsson A, Zakrzewski M, Jörgensen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete healing	Rate (%) of complete healing of hard-to-heal diabetic foot ulcers in Medicare beneficiaries following application of the 3C Patch®.	within 20 weeks of the first application of the 3C Patch.
Secondary	Number of 3C Patch® treatments administered	The number of 3C Patch® treatments administered within 20 weeks of initial application of the 3C Patch®.	20 weeks
Secondary	Major amputation - target limb	The incidence of major (above ankle) amputation affecting the target limb by 24 weeks	24 weeks
Secondary	Major amputation - contralateral limb	The incidence of major amputation affecting the contralateral limb by 24 weeks	24 weeks
Secondary	Minor amputation - target limb	The incidence of minor (below ankle) amputation affecting the target limb by 24 weeks	24 weeks
Secondary	Minor amputation - contralateral limb	The incidence of minor amputation affecting the contralateral limb by 24 weeks	24 weeks