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A Pilot Study to Assess the Efficacy of NEOX® CORD 1K® in the Treatment of Complex Diabetic Wounds

NCT03296436 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2019-02-27

No results posted yet for this study

Summary

Patients presenting to Johns Hopkins with a diabetic ulcer classified by the UT Grade 2 or 3 who meet all of the inclusion and none exclusion criteria and give their informed consent, will receive an application of NEOX CORD 1K in addition to standard of care procedures. Those patients will be seen in follow-up at weekly visits until the wound closes and epithelize, achieving complete closure. Subjects that do not achieve complete ulcer closure prior to or at the end of the 16 treatment weeks will exit the study.

Conditions

  • Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot)
  • Diabetic Foot Ulcer
  • Diabetic Foot
  • Diabetic Foot Infection
  • Diabetic Foot Ulcer Mixed

Interventions

BIOLOGICAL

NEOX® CORD 1K®

NEOX CORD 1K is a cryopreserved human umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility and placenta suitability. NEOX CORD 1K is manufactured by TissueTech Inc. utilizing a proprietary CRYOTEK® process, which devitalizes the living cells but retains the natural structural and biological characteristics relevant to this tissue. NEOX CORD 1K is aseptically processed in compliance with current Good Tissue Practices (cGTP). NEOX CORD 1K of various sizes is stored in a medium of Dulbecco's Modified Eagle Medium/Glycerol (1:1) containing Amphotericin B (an anti-fungal agent). NEOX CORD 1K will be applied to completely cover the wound area and is maintained stationary with sutures or even negative pressure wound therapy after adequate sharp debridement.

Sponsors & Collaborators

Principal Investigators

  • Rondald Sherman, DPM, MBA · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2021-01-31
Completion
2021-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03296436 on ClinicalTrials.gov