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Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01)

NCT03230175 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-06-15

Study results available
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Summary

It is hypothesized that application of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer will, with concomitant management of infection, result in a higher proportion of wounds showing complete healing within 16 weeks of initiating therapy.

Conditions

  • Non-healing Wound
  • Non-healing Diabetic Foot Ulcer
  • Diabetic Foot Infection

Interventions

BIOLOGICAL

TTAX01

TTAX01 will be applied directly to the wound surface and retained with non-absorbable sutures. A single layer of the test article should cover the entire open surface of the wound. The material is to be applied once every 4 weeks unless the wound shows evidence of healing, in which case dosing is suspended; or, if the test article has been accidentally dislodged, it may be replaced at any time.

PROCEDURE

Surgical resection and debridement

Perform surgical sharp debridement in the OR, to remove: * infectious agents and biofilms (purulence), * all debris, eschar, callus and macerated non-viable tissue from the wound base, and * dead (suprabasal epidermis), scarred (elevated/edematous) and necrotic/macerated tissue from the wound edge. Surgical Resection will be performed to remove as much of the necrotic bone detected by the radiographic evidence as is appropriate.

DRUG

Systemic antibiotics

Six (6) weeks of systemic antibiotic therapy is required. A definitive therapy will be guided by the microbiological results based on bone biopsy.

DEVICE

Off-loading

Provide off-loading device appropriate to the location of wound with full length boot or total contact cast

Sponsors & Collaborators

  • BioTissue Holdings, Inc

    lead INDUSTRY

Principal Investigators

  • Scheffer Tseng, MD · Chief Technology Officer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-04
Primary Completion
2019-01-10
Completion
2019-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03230175 on ClinicalTrials.gov