Autologous Skin Substitute for Chronic Leg/Foot Ulcers.

NCT02360358 | Terminated Phase 1

• 1 other identifier: TIS2012
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 5

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.

Conditions

Varicose Ulcer

Outcome Measures

Primary Outcomes (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.

  26 weeks

Secondary Outcomes (8)

• Time in days to complete wound closure from baseline.

  12 weeks

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

  12 weeks

• Percentage of wound closure

  12 and 26 weeks

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

  3 months and 6 months follow up

• Wound size reduction

  12 and 26 weeks

Study Arms (2)

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.

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.

Other: AS210

Interventions

Tiscover DRUG

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

Also known as: autologous skin substitute

autologous cultured skin

AS210 OTHER

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

Also known as: Acellular donor dermis

acellular donor dermis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chantal Blok: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (5)

Centrum Oosterwal

Alkmaar, 1817 MS, Netherlands

Location

Flevo Ziekenhuis, afdeling dermatologie

Almere Stad, Netherlands

Location

VU University Medical center

Amsterdam, 1081HZ, Netherlands

Location

St. Fransiscus Gasthuis

Rotterdam, Netherlands

Location

Isala Ziekenhuis, dermatologie

Zwolle, Netherlands

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Susan Gibss, Prof.dr.

  VU medical center, department of dermatology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: trial coordinator

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 10, 2015
• Study Start: August 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 7, 2016

Record last verified: 2016-01

Locations

NL (5)