Autologous Skin Substitute for Chronic Leg/Foot Ulcers.

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chantal Blok
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development

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