NCT03626623

Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care

Terminated NA Results posted Last updated 25 August 2021

What this trial tests

NA trial testing Cytal Wound Matrix 1-Layer in Diabetes in 15 participants. Terminated before completion.

Timeline

21 May 2019

Primary endpoint
18 February 2020

18 February 2020

Quick facts

Lead sponsor	Integra LifeSciences Corporation
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	21 May 2019
Primary completion	18 February 2020
Estimated completion	18 February 2020
Sites	3 locations across United States

Drugs / interventions tested

• Cytal Wound Matrix 1-Layer
• Standard of Care (SOC) — full drug profile →

Conditions studied

• Diabetes — all drugs for Diabetes →
• Diabetic Foot — all drugs for Diabetic Foot →
• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
• Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →

Sponsor

Integra LifeSciences Corporation — full company profile →

Who can join

21 and older, any sex, with Diabetes or Diabetic Foot. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Wounds With Wound Closure Primary · up to 12 weeks

The primary endpoint of the study is to measure the incidence of complete wound closure (defined as 100% epithelialization) between randomized groups. Number of wounds was calculated as the total across all participants.

Group	Value	95% CI
Standard of Care (SOC)	1
Cytal Wound Matrix 1-Layer	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard of Care (SOC)

Serious: 2/5 (40%)

Deaths: 0/5

Cytal Wound Matrix 1-Layer

Serious: 3/10 (30%)

Deaths: 0/10

Serious adverse events (4 terms)

Reaction	System	Standard of Care (SOC)	Cytal Wound Matrix 1-Layer
infection of target wound/ulcer	Infections and infestations	—	—
cellulitis of target wound/ulcer	Infections and infestations	—	—
chest pain	Cardiac disorders	—	—
elbow infection	Infections and infestations	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	Standard of Care (SOC)	Cytal Wound Matrix 1-Layer
flash burn, eye	Eye disorders	—	—
pneumonia	Respiratory, thoracic and mediastinal disorders	—	—
common cold	General disorders	—	—
wound recurrence (after closure)	General disorders	—	—
new toe wound on target foot	General disorders	—	—
new wound on non-target limb	General disorders	—	—
thumb infection	Infections and infestations	—	—
cellulitis, leg	Infections and infestations	—	—
infection of target wound	Infections and infestations	—	—

Most-reported serious reactions: infection of target wound/ulcer, cellulitis of target wound/ulcer, chest pain, elbow infection.

Data from ClinicalTrials.gov NCT03626623 adverse events section.

Sponsor's own description

This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard care intervention.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Updates on Recent Clinical Assessment of Commercial Chronic Wound Care Products.
   Sharma A, Sharma D, Zhao F. · · 2023 · cited 29× · PMID 37306401 · DOI 10.1002/adhm.202300556