3C Patch® Medicare Claims Study

NCT03997526 | Terminated FDA Device

• 1 other identifier: REAPCEDUS01
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 6

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.

Conditions

Diabetic Foot Ulcer

Keywords

3C Patch; Reapplix; LeucoPatch

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of 3C Patch® treatments administered

  20 weeks

• Major amputation - target limb

  24 weeks

• Major amputation - contralateral limb

  24 weeks

• Minor amputation - target limb

  24 weeks

• Minor amputation - contralateral limb

  24 weeks

Study Arms (1)

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)

Device: 3C Patch

Interventions

3C Patch DEVICE

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

3C Patch treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Medicare beneficiaries diagnosed with diabetic foot ulcer

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Reapplix: lead

Study Sites (6)

Mayo Clinic

Phoenix, Arizona, 84054, United States

Location

Natchitoches Regional Medical Center

Natchitoches, Louisiana, 27514, United States

Location

Opelousas General Hospital Wound Center

Opelousas, Louisiana, 70570, United States

Location

Southeast Wound Care and Hyperbaric Medical Center

Cape Girardeau, Missouri, 63703, United States

Location

Regional One Physician Specialists

Poplar Bluff, Missouri, 63901, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (2)

• 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.

  PMID: 30243803 BACKGROUND

• 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.

  PMID: 25853474 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 25, 2019
• Study Start: July 15, 2020
• Primary Completion: February 21, 2022
• Study Completion: February 21, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)