Leg UlcerPhase 1/2NCT00399308

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

A Phase 1/2 study testing Celaderm (Frozen Cultured Epidermal Allograft) in people with Leg Ulcer and Varicose Ulcer, run by Shire at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Leg Ulcer, Varicose Ulcer
What is being tested?: Celaderm (Frozen Cultured Epidermal Allograft)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 9 sitesUnited States
Study dates: 31 Jan 2007to 30 Apr 2008
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

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

Other trials in United States

About this study

Official title: An Initial Evaluation Of The Safety And Activity Of Celaderm(TM) Treatment Regimens In Healing Venous Leg Ulcers

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.

Conditions: Leg Ulcer, Varicose Ulcer
Being tested: Celaderm (Frozen Cultured Epidermal Allograft), Control (compression bandaging)
Keywords: wound, leg, venous, chronic, wound healing
Medical subject headings: Leg Ulcer, Varicose Ulcer, Wounds and Injuries, Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Celaderm (Frozen Cultured Epidermal Allograft)Device
Also called Frozen Cultured Epidermal Allograft (CEA), Cultured Keratinocytes
Four biweekly applications of Celaderm plus compression therapy
Celaderm (Frozen Cultured Epidermal Allograft)Device
Also called Frozen Cultured Epidermal Allograft (CEA), Cultured Keratinocytes
Four weekly applications of Celaderm plus compression therapy
Control (compression bandaging)Device
Also called Profore
Multi-layer compression bandaging

Study groups in NCT00399308
Study group	Role	What they receive
Control	Active comparator	Multi-layer compression bandaging (Profore) Receives: Device: Control (compression bandaging)
Celaderm, Bi-Weekly	Experimental	Celaderm, bi-weekly applications, up to a maximum of four applications Receives: Device: Celaderm (Frozen Cultured Epidermal Allograft)
Celaderm, Weekly	Experimental	Celaderm, applied weekly, up to a maximum of four applications Receives: Device: Celaderm (Frozen Cultured Epidermal Allograft)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.)
Measured: 12 weeks

Secondary outcomes (3)

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.
Measured: 12 Weeks
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.
Measured: Variable - minimum of 12 weeks of follow-up.
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.
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 200730 Apr 2008

First posted14 Nov 2006 (estimated)
Study start31 Jan 2007
Primary completion30 Apr 2008
Study completion30 Apr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Leg UlcerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00399308
Sponsor's protocol ID: P001-001-B
Status last verified: Jun 2021
First submitted: 10 Nov 2006
Last updated: 11 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer

All Leg Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Initial Evaluation Of The Safety And Activity Of Celaderm(TM) Treatment Regimens In Healing Venous Leg Ulcers
ClinicalTrials.gov ID: NCT00399308
Acronym / sponsor ID: P001-001-B
Conditions: Leg Ulcer, Varicose Ulcer
Keywords: wound, leg, venous, chronic, wound healing
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 31 Jan 2007 (actual)
Primary completion: 30 Apr 2008 (actual)
Study completion: 30 Apr 2008 (actual)
First posted: 14 Nov 2006 (estimated)
Results: Posted 16 May 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Control	Active comparator	Device: Control (compression bandaging)Multi-layer compression bandaging (Profore)
Celaderm, Bi-Weekly	Experimental	Device: Celaderm (Frozen Cultured Epidermal Allograft)Celaderm, bi-weekly applications, up to a maximum of four applications
Celaderm, Weekly	Experimental	Device: Celaderm (Frozen Cultured Epidermal Allograft)Celaderm, applied weekly, up to a maximum of four applications

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Celaderm (Frozen Cultured Epidermal Allograft)Also: Frozen Cultured Epidermal Allograft (CEA), Cultured KeratinocytesFour biweekly applications of Celaderm plus compression therapy	Device	Celaderm, Bi-Weekly
Celaderm (Frozen Cultured Epidermal Allograft)Also: Frozen Cultured Epidermal Allograft (CEA), Cultured KeratinocytesFour weekly applications of Celaderm plus compression therapy	Device	Celaderm, Weekly
Control (compression bandaging)Also: ProforeMulti-layer compression bandaging	Device	Control

Primary outcome

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

3 secondary outcomes

Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment.
Time frame: 12 Weeks
Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period.
Time frame: Variable - minimum of 12 weeks of follow-up.
Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks).
Time frame: 24 weeks

Results and safety

Results posted to the registry on 16 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group I - Weekly Celaderm	13	13
Group II - Bi-weekly Celaderm	15	15
Group III - Control	12	11

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

Time frame: 12 weeks. Number. Unit: participants

Measure	Group I - Weekly Celaderm n = 13	Group II - Bi-weekly Celaderm n = 15	Group III - Control n = 12
Value	1	4	3

Population analysed: Intent-to-Treat population (i.e. all subjects randomized to treatment)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group I - Weekly Celaderm	1 of 13 (7.7%)	3 of 13 (23.1%)	Not reported
Group II - Bi-weekly Celaderm	2 of 15 (13.3%)	2 of 15 (13.3%)	Not reported
Group III - Control	5 of 12 (41.7%)	2 of 12 (16.7%)	Not reported

Limitations and caveats (from the sponsor): Limitations of the trial include the potential for outcome assessment bias as the study was not blinded.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Leg Ulcer

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Celaderm (Frozen Cultured Epidermal Allograft) in people with Leg Ulcer and Varicose Ulcer, run by Shire at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00399308.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.