Varicose UlcerPhase 1/2NCT02360358

Autologous Skin Substitute for Chronic Leg/Foot Ulcers.

A Phase 1/2 study testing Tiscover and AS210 in people with Varicose Ulcer, run by Chantal Blok at 5 sites in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

A prospective, multicenter, randomised controlled phase II study in which patients with therapy resistant (arterio-) venous leg/foot ulcers are treated with Tiscover® (test group) or with AS210 (control group) to determine the safety and relative efficacy of both products. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Varicose Ulcer
What is being tested?: Tiscover and AS210
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 5 sitesNetherlands
Study dates: Aug 2012to Dec 2015
Phase: Phase 1/2
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have a (arterio) venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), or on foot (not plantar side of the foot) with a surface area ≥ 1.0 cm2 and ≤ 40.0 cm2
Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
Arterial supply adequacy confirmed (ABPI ≥ 0.6 and ≤ 1.3)
Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone. Ulcer depth < 1 cm
Target ulcer duration ≥ 12 weeks but ≤ 15 years
Acceptable state of health and nutrition
Mobile, at least able to walk with medical walker, and able to return for required treatments and study evaluations

Who cannot join

History of anaphylaxis, serum sickness, or erythema multiforme reaction to bovine serum proteins, gentamycin.
Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
Refusal of or inability to tolerate compression therapy.
Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.

Show all 15Show fewer

History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
>30% change of wound size in 4 weeks or confirmed by historical data
Presence of deep vein thrombosis or contra indication for compression therapy
Severe co-morbidity reducing life expectance to < 1 year
Use of oral corticosteroids and/or cytostatics >20 mg/per day;
Severe infection of ulcer, active cellulitis, osteomyelitis
Severe malnutrition
Uncontrolled diabetes mellitus, HbA1c > 12% (108 mmol/mol)
Anaemia Hb <6 mmol/l

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Netherlands5 sites

Centrum Oosterwal
Alkmaar, 1817 MS
Flevo Ziekenhuis, afdeling dermatologie
Almere Stad
VU University Medical center
Amsterdam, 1081HZ
St. Fransiscus Gasthuis
Rotterdam
Isala Ziekenhuis, dermatologie
Zwolle

Other trials in Netherlands

About this study

Official title: A Phase II Randomized Multicenter Study on Efficacy and Safety of Cultured Autologous Skin (Tiscover®) and Acellular Dermal Matrix (AS210) in Chronic (Arterio-)Venous Ulcers

Read the detailed description

Multicenter, randomised clinical trial in out patient in which patients with chronic (arterio-) venous leg/foot ulcers are treated with an autologous cultured human living skin substitute (Tiscover®: test group) or with Acellular donor dermis (AS210: control group). During a pre-inclusion evaluation period of 4 weeks (non healing) chronicity of ulcer is ensured (ulcer size change of < 30%). To determine ulcer type ABI, Doppler and CEAP is performed.

The test group will receive 2 applications of Tiscover®. Week 0: wound activating pre-treatment, application of at least one quarter of the wound surface. Week 1: removal of patches, application of patches on total wound surface.

The control group (16 patients) will follow the same application protocol.

Conditions: Varicose Ulcer
Being tested: Tiscover, AS210
Medical subject headings: Varicose Ulcer

What participants receive

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

TiscoverDrug
Also called autologous skin substitute
two step procedure, week 0 and week1. Dosage depends on wound size.
AS210Other
Also called Acellular donor dermis
two step procedure, week 0 and week1. Dosage depends on wound size.

Study groups in NCT02360358
Study group	Role	What they receive
autologous cultured skin	Experimental	autologous cultured skin patches (Tiscover) is applied on wound in 2-step procedure with 1 week interval. Dosage: number of patches depends on wound size. Application week 0 is removed after one week (week1). Week 1: wound is completely covered with new Tiscover patches. Receives: Drug: Tiscover
acellular donor dermis	Active comparator	acellular donor dermis (AS210) is applied on wound in 2-step procedure with 1 week interval. Dosage: number of patches depends on wound size. Application week 0 is removed after one week (week1). Week 1: wound is completely covered with new AS210 patches. Receives: Other: AS210

What is being measured

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

Proportion of subjects with complete wound closure after 26 weeks.
The primary objective of this study is to demonstrate the superiority of Tiscover® compared to AS210 for achieving wound healing in subjects with a chronic (arterio) venous leg or foot ulcer.
Measured: 26 weeks

Secondary outcomes (8)

Time in days to complete wound closure from baseline.
Measured: 12 weeks
• Proportion of subjects with complete wound closure at each of the 12 treatment weeks.
Measured: 12 weeks
Percentage of wound closure
Measured: 12 and 26 weeks
Proportion of subjects with durable wound healing over the 3 months following complete wound closure
Measured: 3 months and 6 months follow up
Wound size reduction
The percentage of reduction in wound area
Measured: 12 and 26 weeks
Pain
Measured with VAS Pain scale
Measured: week 0, 1,2,4,8,12, 26 weeks and follow up
Quality of Life
Measured with SF 36
Measured: Week 0, 12, 26 weeks and follow up
Number of SAE
Measured: 12, 26 weeks and follow up

Timeline

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

Aug 2012Dec 2015

First posted10 Feb 2015 (estimated)
Study startAug 2012
Primary completionDec 2015
Study completionDec 2015

Why it stopped: slow inclusion

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Varicose 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: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02360358
Sponsor's protocol ID: TIS2012
Status last verified: Jan 2016
First submitted: 29 Jan 2015
Last updated: 7 Jan 2016
Results posted: No
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

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PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Not yet recruiting
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Chronic Wounds, Diabetic Foot Ulcer

All Varicose Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Randomized Multicenter Study on Efficacy and Safety of Cultured Autologous Skin (Tiscover®) and Acellular Dermal Matrix (AS210) in Chronic (Arterio-)Venous Ulcers
ClinicalTrials.gov ID: NCT02360358
Acronym / sponsor ID: TIS2012
Conditions: Varicose Ulcer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: slow inclusion
Enrolment: 8 participants (actual)
Lead sponsor: Chantal BlokUniversity, hospital or other
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
Study start: Aug 2012
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 10 Feb 2015 (estimated)
Results: Not posted in the source record

Clinical summary

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

Detailed description

The control group (16 patients) will follow the same application protocol.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
autologous cultured skin	Experimental	Drug: Tiscoverautologous cultured skin patches (Tiscover) is applied on wound in 2-step procedure with 1 week interval. Dosage: number of patches depends on wound size. Application week 0 is removed after one week (week1). Week 1: wound is completely covered with new Tiscover patches.
acellular donor dermis	Active comparator	Other: AS210acellular donor dermis (AS210) is applied on wound in 2-step procedure with 1 week interval. Dosage: number of patches depends on wound size. Application week 0 is removed after one week (week1). Week 1: wound is completely covered with new AS210 patches.

Who may qualify

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

Key inclusion criteria (7 listed)

Have a (arterio) venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), or on foot (not plantar side of the foot) with a surface area ≥ 1.0 cm2 and ≤ 40.0 cm2
Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
Arterial supply adequacy confirmed (ABPI ≥ 0.6 and ≤ 1.3)
Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone. Ulcer depth < 1 cm
Target ulcer duration ≥ 12 weeks but ≤ 15 years

Key exclusion criteria (15 listed)

History of anaphylaxis, serum sickness, or erythema multiforme reaction to bovine serum proteins, gentamycin.
Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
Refusal of or inability to tolerate compression therapy.

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
TiscoverAlso: autologous skin substitutetwo step procedure, week 0 and week1. Dosage depends on wound size.	Drug	autologous cultured skin
AS210Also: Acellular donor dermistwo step procedure, week 0 and week1. Dosage depends on wound size.	Other	acellular donor dermis

Primary outcome

Proportion of subjects with complete wound closure after 26 weeks.
Time frame: 26 weeks
The primary objective of this study is to demonstrate the superiority of Tiscover® compared to AS210 for achieving wound healing in subjects with a chronic (arterio) venous leg or foot ulcer.

8 secondary outcomes

Time in days to complete wound closure from baseline.
Time frame: 12 weeks
• Proportion of subjects with complete wound closure at each of the 12 treatment weeks.
Time frame: 12 weeks
Percentage of wound closure
Time frame: 12 and 26 weeks
Proportion of subjects with durable wound healing over the 3 months following complete wound closure
Time frame: 3 months and 6 months follow up
Wound size reduction
Time frame: 12 and 26 weeks
Pain
Time frame: week 0, 1,2,4,8,12, 26 weeks and follow up
Quality of Life
Time frame: Week 0, 12, 26 weeks and follow up
Number of SAE
Time frame: 12, 26 weeks and follow up

Results and safety

The study was stopped early (reason given: slow inclusion). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.

Related trials for Varicose Ulcer

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Not yet recruiting
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Chronic Wounds, 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.

Susan Gibss, Prof.dr. study chair

VU medical center, department of dermatology

5 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 Tiscover and AS210 in people with Varicose Ulcer, run by Chantal Blok at 5 sites in Netherlands.

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 7 inclusion and 15 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: stopped early, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands. 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?

The study was stopped early (reason given: slow inclusion). Results are not available in the source record.

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?

Proportion of subjects with complete wound closure after 26 weeks. (time frame: 26 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 NCT02360358.

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 7 Jan 2016; AzTrials last refreshed its copy on 8 Nov 2026.