NCT00399308

Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers

Completed Phase 1, PHASE2 Results posted Last updated 11 June 2021

What this trial tests

Phase 1, PHASE2 trial testing Celaderm (Frozen Cultured Epidermal Allograft) in Leg Ulcer in 40 participants. Completed in 30 April 2008.

Timeline

31 January 2007

Primary endpoint
30 April 2008

30 April 2008

Quick facts

Lead sponsor	Shire
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	31 January 2007
Primary completion	30 April 2008
Estimated completion	30 April 2008
Sites	9 locations across United States

Drugs / interventions tested

• Celaderm (Frozen Cultured Epidermal Allograft)
• Celaderm (Frozen Cultured Epidermal Allograft)
• Control (compression bandaging)

Conditions studied

• Leg Ulcer — all drugs for Leg Ulcer →
• Varicose Ulcer — all drugs for Varicose Ulcer →

Sponsor

Shire — full company profile →

Who can join

Adults 18 to 80, any sex, with Leg Ulcer or Varicose Ulcer. 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.

Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation. Primary · 12 weeks

The primary efficacy observation was the proportion of wounds that achieved complete wound closure after 12 weeks of active treatment (i.e. of of Week 15 including screening/wash-in phase.)

Group	Value	95% CI
Group I - Weekly Celaderm	1
Group II - Bi-weekly Celaderm	4
Group III - Control	3

Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment. Secondary · 12 Weeks

Re-epithelialization was judged by the Medical Monitor based upon computerized planimetry of serial wound photographs.

Group	Value	95% CI
Group I - Weekly Celaderm	1
Group II - Bi-weekly Celaderm	5
Group III - Control	3

Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period. Secondary · Variable - minimum of 12 weeks of follow-up.

The proportion of patients who had a recurrence of the study ulcer during follow-up after achieving wound closure during the active treatment period.

Group	Value	95% CI
Group I - Weekly Celaderm	0
Group II - Bi-weekly Celaderm	1
Group III - Control	0

Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks). Secondary · 24 weeks

The proportion of patients achieving wound closure by the end of the study follow-up period, 90 days after the end of the active treatment period.

Group	Value	95% CI
Group I - Weekly Celaderm	3
Group II - Bi-weekly Celaderm	7
Group III - Control	5

Adverse events — posted to ClinicalTrials.gov

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

Group I - Weekly Celaderm

Serious: 1/13 (8%)

Deaths: —

Group II - Bi-weekly Celaderm

Serious: 2/15 (13%)

Deaths: —

Group III - Control

Serious: 5/12 (42%)

Deaths: —

Serious adverse events (7 terms)

Reaction	System	Group I - Weekly Celaderm	Group II - Bi-weekly Celad…	Group III - Control
Cellulitis	Skin and subcutaneous tissue disorders	—	—	—
Acute Exacerbation of Chronic Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—
Urinary Tract Infection	Infections and infestations	—	—	—
Critical Limb Ischemia	Vascular disorders	—	—	—
Chest Pain	Cardiac disorders	—	—	—
Swelling	General disorders	—	—	—
Siezure	Nervous system disorders	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Group I - Weekly Celaderm	Group II - Bi-weekly Celad…	Group III - Control
Ulcer Infection	Infections and infestations	—	—	—

Most-reported serious reactions: Cellulitis, Acute Exacerbation of Chronic Asthma, Urinary Tract Infection, Critical Limb Ischemia, Chest Pain, Swelling, Siezure.

Data from ClinicalTrials.gov NCT00399308 adverse events section.

Sponsor's own description

This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg ulcers and to give preliminary information about the efficacy of two different Celaderm(TM) dosing regimens.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.