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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.

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

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 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 groupRoleWhat they receive
autologous cultured skinExperimentalautologous 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 dermisActive comparatoracellular 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.

  1. 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)

  1. Time in days to complete wound closure from baseline.

    Measured: 12 weeks

  2. • Proportion of subjects with complete wound closure at each of the 12 treatment weeks.

    Measured: 12 weeks

  3. Percentage of wound closure

    Measured: 12 and 26 weeks

  4. Proportion of subjects with durable wound healing over the 3 months following complete wound closure

    Measured: 3 months and 6 months follow up

  5. Wound size reduction

    The percentage of reduction in wound area

    Measured: 12 and 26 weeks

  6. Pain

    Measured with VAS Pain scale

    Measured: week 0, 1,2,4,8,12, 26 weeks and follow up

  7. Quality of Life

    Measured with SF 36

    Measured: Week 0, 12, 26 weeks and follow up

  8. 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.

  1. First posted10 Feb 2015 (estimated)
  2. Study startAug 2012
  3. Primary completionDec 2015
  4. Study completionDec 2015

Why it stopped: slow inclusion

Resources

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

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.

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