Overview

This trial is active, not recruiting.

Condition venous leg ulcers
Treatment hp802-247
Phase phase 2
Sponsor Smith & Nephew, Inc.
Start date July 2014
End date July 2015
Trial size 25 participants
Trial identifier NCT02154087, 802-247-09-034

Summary

Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacodynamics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
hp802-247
260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle

Primary Outcomes

Measure
Determine change from baseline in cell numbers in subjects with VLU following the first dose of HP802-247
time frame: 5 weeks
= Determine change from baseline in cell types in subjects with VLU following the first dose of HP802-247
time frame: 5 weeks
= Determine change from baseline in biochemical markers of inflammation in subjects with VLU following the first dose of HP802-247
time frame: 5 weeks

Secondary Outcomes

Measure
Wound closure, defined as complete re-epithelization with no drainage or need for a dressing, will be recorded as a secondary outcome measure following up to 12 weeks of dosing
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Provide informed consent - Age ≥ 18 years and of either sex - Willing to comply with protocol instructions, including allowing all study assessments - Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 4.0 cm x cm and ≤ 15.0 cm x cm - Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence - Arterial supply adequacy confirmed - Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone - Target ulcer duration ≥ 12 weeks but ≤ 104 weeks (24 months). - Acceptable state of health and nutrition Exclusion Criteria: - History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B or any other component of HP802-247,or known sensitivity to Iodine - Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication - Therapy with another investigational agent within thirty (30) days of Screening, or during the study, or any participation in a previous HP802-247 trial - 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 Collagenase Santyl® ointment, autologous skin graft, biological dressings or living cell products (e.g., Oasis®, Apligraf™, Dermagraft™) within 30 days preceding the Screening Visit - Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit - Current therapy with systemic antibiotics - Current systemic therapy with cytotoxic drugs - Current therapy with chronic (> 10 days) oral corticosteroids - Current therapy with TNFα inhibitors - History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)

Additional Information

Official title A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Smith & Nephew, Inc..