Evaluation of Integra® Artificial Dermis for the Treatment of Leg Ulcers

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01285973

Enrollment

Registered

2011-01-28

Start date

2011-04-30

Completion date

2015-08-31

Last updated

2015-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Limb Ulcer

Brief summary

The aim of this prospective study is to assess the utility of treatment of leg ulcers using a skin substitute, Integra®, assessing the quality of wound skin healing and transcutaneous oxygen pressure in the distal region of the wound. This is a multi-centre study on 60 patients who have a lower limb ulcer.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* patient with a lower limb ulcer, regardless of origin (arterial, venous or mixed, diabetic foot ulcer) present for more than 6 months or large in size (\> 10 cm²) * patients in whom the surgeon has recommended that an Integra® matrix be implanted (even if the patient is not taking part in the study) before the dermo-epidermal graft to obtain a richly vascularised neodermis. * not eligible for skin flap surgery, * the patient or patient's representative has agreed to sign the information letter before any investigation required by the research.

Exclusion criteria

* circumferential wound, * wound infection * immunosuppressed patient, * known allergy to bovine collagen, bovine glycosaminoglycans or silicone, * patients under legal guardianship, * pregnant women * patients whose health would compromise follow-up for at least 18 months, * patients whose mental health would compromise completion of the self-evaluation questionnaires. * wound located in an area not visible by the patient (as no self-assessment would be possible).

Design outcomes

Primary

Measure	Time frame
Proportion of patients with a greater than 50% reduction in wound surface area during the 18 months after grafting.	18 months

Secondary

Measure	Time frame
Functional complications of healing at 3, 6, 12 and 18 months	3, 6, 12 and 18 months
Complete wound healing (reduction in wound surface area >90%)	3, 6, 12, 18 months
Pain	3, 6, 12, 18 months
Quality of life	3, 6, 12, 18 months
Transcutnaeous oxygen pressure (TcPO2)	6, 12 and 18 months

Countries

France, Greece, Italy

Outcome results