Autologous Skin Substitute for Chronic Leg/Foot Ulcers.

NCT ID: NCT02360358

Last Updated: 2016-01-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

autologous cultured skin

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.

Group Type: EXPERIMENTAL

Tiscover

Intervention Type: DRUG

two step procedure, week 0 and week1. Dosage depends on wound size.

acellular donor dermis

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.

Group Type: ACTIVE_COMPARATOR

AS210

Intervention Type: OTHER

two step procedure, week 0 and week1. Dosage depends on wound size.

Interventions

Tiscover

two step procedure, week 0 and week1. Dosage depends on wound size.

Intervention Type: DRUG

AS210

two step procedure, week 0 and week1. Dosage depends on wound size.

Intervention Type: OTHER

Other Intervention Names

autologous skin substitute; Acellular donor dermis

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Chantal Blok

OTHER

Sponsor Role: lead

Responsible Party

Chantal Blok

trial coordinator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Susan Gibss, Prof.dr.

Role: STUDY_CHAIR

VU medical center, department of dermatology

Locations

Centrum Oosterwal

Alkmaar, , Netherlands

Flevo Ziekenhuis, afdeling dermatologie

Almere Stad, , Netherlands

VU University Medical center

Amsterdam, , Netherlands

St. Fransiscus Gasthuis

Rotterdam, , Netherlands

Isala Ziekenhuis, dermatologie

Zwolle, , Netherlands

Countries

Netherlands

Other Identifiers

TIS2012

Identifier Type: -

Identifier Source: org_study_id