A Study to Evaluate the Reapplix 3C Patch® System to Treat Diabetic Foot Ulcers

Overview

About this study

The purpose of this study is to compare incidence rates of complete hard-to-heal diabetic foot ulcer healing in Medicare beneficiaries following application of the 3C Patch® plus usual care (i.e., care consistent with the International Working Group on the Diabetic Foot guidelines), tested against a historical control group of similar patients that received usual care during a randomized controlled trial.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • People aged 65 years and over who have diabetes complicated by one or more ulcers on a foot or both feet below the level of the malleoli, excluding ulcers confined to the interdigital cleft.
  • Those with more than one eligible ulcer will have one – usually the largest or more clinically significant – selected as the index ulcer.
  • Eligible ulcers will be hard-to-heal, meaning that the cross-sectional area will decrease by less than 50% during a four (4) week period prior to the first application of the 3C Patch® (percentage determined clinically by the treating physician by estimation at examination).
  • Cross-sectional area must increase by less than 25% during a four week period prior to the first application of the 3C Patch® (percentage determined clinically by the treating physician by estimation at examination).
  • The cross-sectional area of the index ulcer will be between ≥ 50 and ≤ 1000 mm^2 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 anaemia, haemophilia, thrombocytopenia (< 100x10^9 /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 at randomization.
  • Revascularization procedure in the affected limb 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 preceding 8 weeks.
  • The need for continued use of negative pressure wound therapy.
  • Likely inability to comply with the need for periodic visits because of planned activity.
  • Participation in another interventional clinical foot ulcer-healing study within 4 weeks of the first application of the 3C Patch® .
  • Prior enrolment 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Erwin Kruger, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20504793

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