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CompletedNCT00399308Updated Jun 11, 2021Results posted

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

A Phase 1/2 interventional study of Celaderm (Frozen Cultured Epidermal Allograft) and Celaderm (Frozen Cultured Epidermal Allograft) in Leg Ulcer and Varicose Ulcer, sponsored by Shire. Completed at 9 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-06-11.

Sponsored by Shire · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the detailed description

Celaderm(TM) weekly for four weeks or biweekly for four treatments combined with Profore(R) compression vs. Profore(R) compression alone.

02

Conditions studied

  • Leg Ulcer
  • Varicose Ulcer

Keywords

  • wound
  • leg
  • venous
  • chronic
  • wound healing
03

In context

Varicose Ulcer

378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.

This study's enrollment of 40 is below the median of 64 across 325 interventional studies indexed under Varicose Ulcer.

Browse Varicose Ulcer studies →

Lead sponsor

Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • venous ulcer > 1 month and \< 12 months in duration; 2 to 20 sq cm in surface area; not infected
  • confirmatory venous ultrasound showing prior DVT and concurrent venous reflux
  • ankle-brachial index 0.80 or greater

Exclusion criteria

Exclusion Criteria:

  • cutaneous malignancy
  • recent treatment with corticosteroids or chemotherapeutic agents
  • wound exposed bone, tendon or neurovascular structure
  • wound infected and requiring antibiotics
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Control

    Multi-layer compression bandaging (Profore)

    Device: Control (compression bandaging)

  • Experimental
    Celaderm, Bi-Weekly

    Celaderm, bi-weekly applications, up to a maximum of four applications

    Device: Celaderm (Frozen Cultured Epidermal Allograft)

  • Experimental
    Celaderm, Weekly

    Celaderm, applied weekly, up to a maximum of four applications

    Device: Celaderm (Frozen Cultured Epidermal Allograft)

Interventions

  • DeviceCeladerm (Frozen Cultured Epidermal Allograft)

    Four biweekly applications of Celaderm plus compression therapy

    Also known as: Frozen Cultured Epidermal Allograft (CEA), Cultured Keratinocytes

  • DeviceCeladerm (Frozen Cultured Epidermal Allograft)

    Four weekly applications of Celaderm plus compression therapy

    Also known as: Frozen Cultured Epidermal Allograft (CEA), Cultured Keratinocytes

  • DeviceControl (compression bandaging)

    Multi-layer compression bandaging

    Also known as: Profore

06

What researchers measure

Primary outcomes

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

    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.)

    Time frame: 12 weeks

Secondary outcomes

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

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

    Time frame: 12 Weeks

  2. Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period.

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

    Time frame: Variable - minimum of 12 weeks of follow-up.

  3. Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (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.

    Time frame: 24 weeks

07

Results

Posted May 16, 2013
Limitations and caveats
Limitations of the trial include the potential for outcome assessment bias as the study was not blinded.

Participant flow

An enrollment of 55 patients was planned to produce an expected yield of approximately 45 evaluable patients at up to nine study centers.

Participant flow — Overall Study
MilestoneGroup I - Weekly CeladermGroup II - Bi-weekly CeladermGroup III - Control
Started131512
Completed131511
Not completed001

Outcome measures

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

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.)

Time frame:
12 weeks
Reported as:
Number · participants
Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation.
participantsGroup I - Weekly CeladermGroup II - Bi-weekly CeladermGroup III - Control
Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation.143
SecondarySecondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment.

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

Time frame:
12 Weeks
Reported as:
Number · participants
Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment.
participantsGroup I - Weekly CeladermGroup II - Bi-weekly CeladermGroup III - Control
Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment.153
SecondarySecondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period.

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

Time frame:
Variable - minimum of 12 weeks of follow-up.
Reported as:
Number · participants
Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period.
participantsGroup I - Weekly CeladermGroup II - Bi-weekly CeladermGroup III - Control
Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period.010
SecondarySecondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (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.

Time frame:
24 weeks
Reported as:
Number · participants
Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks).
participantsGroup I - Weekly CeladermGroup II - Bi-weekly CeladermGroup III - Control
Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks).375

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group I - Weekly Celaderm—1/13 (7.7%)3/13 (23.1%)
Group II - Bi-weekly Celaderm—2/15 (13.3%)2/15 (13.3%)
Group III - Control—5/12 (41.7%)2/12 (16.7%)
Most frequent serious events
Most frequent serious events
EventGroup I - Weekly CeladermGroup II - Bi-weekly CeladermGroup III - Control
CellulitisSkin and subcutaneous tissue disorders0/131/151/12
Urinary Tract InfectionInfections and infestations0/130/151/12
Critical Limb IschemiaVascular disorders0/130/151/12
Chest PainCardiac disorders0/130/151/12
SwellingGeneral disorders0/130/151/12
SiezureNervous system disorders1/130/150/12
Acute Exacerbation of Chronic AsthmaRespiratory, thoracic and mediastinal disorders0/131/150/12
Most frequent other events
Most frequent other events
EventGroup I - Weekly CeladermGroup II - Bi-weekly CeladermGroup III - Control
Ulcer InfectionInfections and infestations3/132/152/12

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Group I - Weekly CeladermGroup II - Bi-weekly CeladermGroup III - ControlTotal
<=18 years0000
Between 18 and 65 years614929
>=65 years71311
Age, Continuous
Age, Continuous(years)Group I - Weekly CeladermGroup II - Bi-weekly CeladermGroup III - ControlTotal
Mean67.54 ± 12.6560.40 ± 8.7564 ± 12.8565.28 ± 11.5
Sex: Female, Male
Sex: Female, Male(Participants)Group I - Weekly CeladermGroup II - Bi-weekly CeladermGroup III - ControlTotal
Female39416
Male106824
Region of Enrollment
Region of Enrollment(Participants)Group I - Weekly CeladermGroup II - Bi-weekly CeladermGroup III - ControlTotal
United States13151240
08

Study locations

9 sites
  • Dr. Robert Snyder
    Tamarac, Florida 33321, United States
  • National Center for Limb Preservation
    Niles, Illinois 60714, United States
  • Beth Israel Deaconess Medical Center, Division of Podiatry
    Boston, Massachusetts 02215, United States
  • Center for Curative & Palliative Wound Care, Calvary Hospital
    Bronx, New York 10461, United States
  • State University of New York Stony Brook
    Stony Brook, New York 11794, United States
  • University of North Carolina at Chapel Hill, Division of Vascular Surgery
    Durham, North Carolina 27599, United States
  • Blair Medical Associates, Inc., Station Medical Center, Associates Wound Clinic
    Altoona, Pennsylvania 16602, United States
  • Peripheral Vascular Associates, P.A.
    San Antonio, Texas 78205, United States
  • Dixie Regional Medical Center, Wound Care
    Saint George, Utah 84770, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00399308
Lead sponsor
Shire
Responsible party
Sponsor
First posted
Nov 14, 2006
Start date
Jan 31, 2007
Primary completion
Apr 30, 2008
Completion
Apr 30, 2008
Results posted
May 16, 2013
Last update
Jun 11, 2021

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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