Venous Stasis Ulcers
Conditions
Brief 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.
Detailed description
Abnormal wound healing is characterized by prolonged inflammation and excess degradation of the extracellular matrix through the activity of proteinases and other enzymes. Wound fluids can provide biochemical information about the healing status of chronic wounds and the effects of wound treatments. In this study the investigators will obtain samples of wound fluid and measure healing in wounds randomized to receive the novel dressing or a control. The findings will be compared between the two groups.
Interventions
DEVICENovel Dressing
Topical wound dressing
Sponsors
Hollister Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Matrix Metalloproteinase Level in Wound Fluid | 8 weeks | Wound fluid will be collected and analyzed at baseline and approximately every 7 days. Mean was calculated for each subject. Means and standard deviation were calculated for the treatment and control groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing | 12 weeks | change in wound area mean was calculated for each subject Mean and sd were calculated for each group |
Countries
United States
Participant flow
Pre-assignment details
4 subjects attended only one study visit thus did not have evaluable data
Participants by arm
| Arm | Count |
|---|---|
| Novel Dressing Treatment with novel dressing
Novel Dressing: Topical wound dressing | 19 |
| Control Control is treatment without novel dressing | 16 |
| Total | 35 |
Baseline characteristics
| Characteristic | Novel Dressing | Control | Total |
|---|---|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 14.9 | 60.6 years STANDARD_DEVIATION 12.9 | 58.1 years STANDARD_DEVIATION 14 |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 12 Participants | 9 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 16 |
| serious Total, serious adverse events | 0 / 19 | 0 / 16 |
Outcome results
Primary
Matrix Metalloproteinase Level in Wound Fluid
Wound fluid will be collected and analyzed at baseline and approximately every 7 days. Mean was calculated for each subject. Means and standard deviation were calculated for the treatment and control groups.
Time frame: 8 weeks
Population: Overall mean across 8 week timeframe
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Novel Dressing | Matrix Metalloproteinase Level in Wound Fluid | 0.71 mcg/ml | Standard Deviation 0.78 |
| Control | Matrix Metalloproteinase Level in Wound Fluid | 0.88 mcg/ml | Standard Deviation 0.85 |
Secondary
Wound Healing
change in wound area mean was calculated for each subject Mean and sd were calculated for each group
Time frame: 12 weeks
Population: average across 12 week time frame
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Novel Dressing | Wound Healing | -4.99 square cm | Standard Deviation 8.22 |
| Control | Wound Healing | -2.49 square cm | Standard Deviation 6.45 |