Phase 4 N=39 Randomized Treatment

Wound Fluid Protease Levels During Use of Novel Wound Dressing

Venous Stasis Ulcers

Bottom Line

View on ClinicalTrials.gov: NCT01567150 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2016

Primary outcome: Primary: Matrix Metalloproteinase Level in Wound Fluid — 0.71; 0.88 mcg/ml

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Novel Dressing (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hollister Incorporated
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Matrix Metalloproteinase Level in Wound Fluid	0.71; 0.88	—
SECONDARY Wound Healing	-4.99; -2.49	—

Summary

This study is being conducted to characterize the way leg wounds respond to a new type of wound dressing, compared to wounds in patients who are not using the new dressing. The investigators will collect wound fluid for biochemical analysis, and they will measure the wound healing that occurs with and without the new dressing.

Eligibility Criteria

Inclusion Criteria

Diagnosis of venous insufficiency
One or more partial or full-thickness venous leg ulcers 5-24 sq. cm in size without evidence of clinical infection
Ankle/brachial index 0.8 and above
Duration of wound up to one year
Able to return to wound clinic for weekly evaluations
Has signed Institutional Review Board approved informed consent

Exclusion Criteria

Exposed bone or tendon or necrotic wound base
Signs or symptoms of cellulitis or osteomyelitis at the target ulcer
Allergy to a component of the novel dressing or compression wrap
Third degree burn
Vasculitis, severe rheumatoid arthritis or other collagen vascular disease
Receiving antibiotics
Pregnant or lactating

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01567150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.