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An open, non-comparative, multi-centre post marketing clinical follow-up, PMCF, investigation to evaluate performance and safety on diabetic foot ulcer, dfu, when using mepilex transfer Ag as intended.
Approximately 25-30 subjects from two to three centers will be evaluated provided they fulfill the inclusion criteria and none of the exclusion criteria and gives a signed and dated consent.
Subjects to be included were to suffer from a DFU and being in need of anti-microbial wound dressing.
Dressing changes were to performed according to the local clinical routine (usually 3 times/week), evaluated during a total treatment period of maximum 4 weeks including weekly visits when assessments were being done. A record (dressing log) for Mepilex Transfer Ag and outer layers were to be filled in at every dressing change.
Photos taken directly upon dressing removal and after cleansing /debridement were to be collected to visually follow the ulcers status.
At each visit the investigators/nurse and subjects opinion (using an evaluation form) were to be asked for questions considering the use of Mepilex Transfer Ag. Pain before, during and after removal will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepilex Transfer Ag | Experimental | Mepilex Transfer Ag is a transfer dressing designed for low to high exuding wounds and used to prevent microbial growth. It is worn for up to two weeks at a time. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepilex Transfer Ag | Device | A soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Signs and Symptoms of Local Infection | Evaluation of signs of infection (exudate) from baseline | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of Pain in Connection to Dressing Changes. | Levels of pain measured by VAS, visual analog scale. 1 to 100 mm, 1= low pain, 100= worse pain. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ketan Dhatariya, Doctor | Norfolk & Norwich University Hospitals NHS foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Norfolk & Norwich University Hospitals NHS foundation | Norwich | Colney Lane | NR4 7UY | United Kingdom | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Mepilex Transfer Ag | Mepilex Transfer Ag is a transfer dressing designed for low to high exuding wounds and used to prevent microbial growth. It is worn for up to two weeks at a time. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| The Rotherham NHS Foundation Trust |
| Rotherham |
| S60 2UD |
| United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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Adult subjects with diabetic foot ulcers
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| ID | Title | Description |
|---|---|---|
| BG000 | Mepilex Transfer Ag | An open, non-comparative study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Signs and Symptoms of Local Infection | Evaluation of signs of infection (exudate) from baseline | ITT | Posted | Count of Participants | Participants | 4 weeks |
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| Secondary | Levels of Pain in Connection to Dressing Changes. | Levels of pain measured by VAS, visual analog scale. 1 to 100 mm, 1= low pain, 100= worse pain. | For some patients pain assessment was not performed at all predefined timepoints. Therefore some data were not collected. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mepilex Transfer Ag | An open, non-comparative study. | 7 | 24 | 1 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pulmonary embolism | General disorders |
| |||
| psuedo-gout of wrist | General disorders |
| |||
| wound infection | Infections and infestations |
| |||
| Wound deterioration | General disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ankle pain | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ketan Dhatariya | The Norfolk & Norwich University Hospitals NHS Foundation Trust | +44 1603 286286 | ketan.dhatariya@nnuh.nhs.uk |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Baseline |
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| Week 1 |
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| Week 2 |
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| Week 3 |
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| Week 4 |
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