Diabetic Foot Ulcer Clinical Trial
Official title:
A Prospective, Randomized, Controlled Study Using Cross-Over Design to Evaluate and Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
Verified date | January 2020 |
Source | Molnlycke Health Care AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.
Status | Completed |
Enrollment | 40 |
Est. completion date | November 15, 2019 |
Est. primary completion date | October 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. Male and female subjects 18-85 years of age with leg and foot ulcers (i.e. VLU, DFU). 2. Signed informed consent. 3. Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages when applicable and offloading footwear. 4. Study subject must be available and able to visit the clinic weekly for the full 4-week period. Exclusion Criteria: 1. Pressure ulcers should not be included. Pressure injury as defined by the National Pressure Ulcer Advisory Panel (NPUAP). 2. Presence of local wound infection as determined by study doctor based on clinical signs and symptoms. 3. Subject has any evidence of peripheral arterial disease (PAD). 4. Subject diagnosed with malignancy other than cutaneous basal cell carcinoma. 5. Subject has received growth factor therapy (e.g. autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix e.g. amnion, amniotic tissue) within 2 weeks of screening date. 6. Pregnancy or lactation at time of study participation. 7. Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization. 8. Subject is currently enrolled or participated in another investigational device, drug or biological trial within 30 days of baseline of this study. 9. Present history of alcohol or drug abuse. 10. Known allergy/hypersensitivity to any of the components of the dressing. 11. Subject not suitable for the investigation according to the investigator's judgment. |
Country | Name | City | State |
---|---|---|---|
United States | Center for Clinical Research, Inc. | Castro Valley | California |
United States | Vascular and Wound Care Center | Newark | New Jersey |
United States | SerenaGroup | Pittsburgh | Pennsylvania |
United States | SerenaGroup Research Foundation | Pittsburgh | Pennsylvania |
United States | Center for Clinical Trials, Inc. | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Molnlycke Health Care AB |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | % of Participants With Equal or Better Rate of Dressing Durability | Dressing strike-through determined @ Wk1 Day 3&7, and Wk3 Day 17&21. Dressing strike-through that occurred Day 3 and/or 7, Day 17 and/or 21 were included in final dataset.
Contributing factors to strike-through: Saturation of dressing pad: Inappropriate dressing type Inappropriate dressing change freq. (i.e. more frequent changes required) Change in wound condition (e.g. increase in exudate amt) Dislodgement of dressing: Suboptimal dressing application (e.g. selection of inappropriate dressing size, failure to clean periwound skin before applying dressing, insufficient fixation) Exposure of dressing to mechanical forces (e.g. off-loading devices, patient mobility) Patient interference w/ dressing Dressing design deficiency: Insufficient fluid handling capacity (absorption, retention and/or moisture vapor transmission) Insufficient adhesion Insufficient conformability (i.e. ability to conform to body contours & challenging anatomical wound locations) |
4 weeks | |
Primary | % of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21 | Intact dressing after 7 days wear time, assessed @ Wk1 Day7 & Wk3 Day21 only. 1st week of dressing wear (Wks 1 & 3) is critical for start of wound healing.
Contributing factors to strike-through: Saturation of dressing pad: Inappropriate dressing type Inappropriate dressing change freq. (i.e. more frequent changes required) Change in wound condition (e.g. increase in exudate amt) Dislodgement of dressing: Suboptimal dressing application (e.g. selection of inappropriate dressing size, failure to clean periwound skin before applying dressing, insufficient fixation) Exposure of dressing to mechanical forces (e.g. off-loading devices, patient mobility) Patient interference w/ dressing Dressing design deficiency: Insufficient fluid handling capacity (absorption, retention and/or moisture vapor transmission) Insufficient adhesion Insufficient conformability (i.e. ability to conform to body contours & challenging anatomical wound locations) |
Weeks 1 and 3 | |
Secondary | % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Before Dressing Removal With Five-layer | Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever. | 4 weeks | |
Secondary | % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain at Removal With Five-layer | Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever. | 4 weeks | |
Secondary | % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Immediately After Dressing Removal With Five-layer | Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever. | 4 weeks | |
Secondary | % of Participants With Equal or Better Outcomes With Five-layer in Evaluation of the Dressings | Dressing evaluation was determined via visual observation by study clinicians and categorized by saturation level: Partly saturated, Mostly saturated, and Strike-through. | 4 weeks | |
Secondary | % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wound Granulation | Wound granulation was measured by visual assessment and photodigital planimetry. Wound granulation were grouped into 6 categories: None, <25%, 25-49%, 50-74%, 75-99%, 100%. | 4 weeks | |
Secondary | % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wounds for Non-viable Tissue (Eschar, Fibrin Slough, Both) | Non-viable tissue was determined by visual assessment and photodigital planimetry. Non-viable tissues were grouped into 5 categories: None, <25%, 25-49%, 50-74%, 75-100%. | 4 weeks | |
Secondary | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | The SF-12 health survey consists of 12 questions that yield an eight-scale profile of functional health and well-being, and 2 component summary measures of physical and mental health. SF-12 scores range from 0 to 100 with lower scores indicate lower levels of health.
SF-12 questionnaire was administered at Screening/Baseline, Day 14, and Day 28 visits, and scored by a 3rd party vendor. Results are mean differences between five-layer vs the comparator dressing and presented for each of the 8 health domains, and 2 component summary measures. Negative scores indicate lower SF-12 scores (indicating lower levels of health) for the five-layer treatment group; positive scores indicate higher SF-12 scores for the five-layer group. |
4 weeks |
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