A Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

Overview

About this study

The primary objective of the study is to assess the safety of a novel biomaterial nerve scaffold, polycaprolactone fumarate (PCLF) conduit.

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:

  • Are between the ages of 18-75 years.
  • Have clinical indications for whole sural nerve biopsy.
  • Have a sural nerve SNAP with amplitude > or = 2 μV.
  • Are able to comply with protocol requirements.
  • Can provide written informed consent.
  • Willingness to complete study procedures.

Exclusion Criteria:

  • Current smoker.
  • History of prior musculoskeletal (joint or soft tissue) infection.
  • Pre-operative nares culture positive for methicillin-resistant Staphylococcus Aureus (MRSA) or methicillin-sensitive Staphylococcus Aureus (MSSA)
  • Have systemic immune disorders, such as Crohn’s Disease, rheumatoid arthritis, or psoriasis with the exception of hyper/hypothyroidism.
  • Have diabetes mellitus.
  • Have previous trauma to the biopsy site.
  • Have any major, clinically significant medical condition (e.g., within six months of baseline, had myocardial infarction, angina pectoris, and/or congestive heart failure) that, in the opinion of the investigator, would compromise the safety of patient.
  • Any of the following because this study involves an investigational device of which the effects on pregnant women, the developing fetus and newborn are unknown:
    • Pregnant women.
    • Nursing women.
    • Men or women of childbearing potential (WOCBP) who are unwilling to employ adequatecontraception.
      • Note: WOCBP must agree to follow instructions for method(s) of contraception for the duration of the study, for 2 years following implantation of the device.
    • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of the study, for 2 years following implantation of the device.
    • Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However they must still undergo pregnancy testing as described in this section.
      • Note: Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < 1% when used consistently and correctly.
  • At a minimum, subjects must agree to the use of one method of highly effective contraception as listed below:
    • Male condoms with spermicide
    • Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) such as Mirena® by WOCBP subject or male subject’s WOCBP partner.
    • Female partners of male subjects participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug.
    • IUDs, such as ParaGard®.
    • Tubal ligation.
    • Vasectomy.
    • Complete Abstinence*.
  • *Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence.

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Anthony Windebank, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Michelle Turner

(507) 284-1223

Turner.Michelle@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20429226

Mayo Clinic Footer