Diabetic Foot Ulcers
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMepilex Transfer Ag
A soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Both gender\>=18 years old 2. Subjects with type 1 or 2 diabetes mellitus 3. Two of the signs of infection must be present and recorded (redness, heat, oedema, pain, increased exudates amount, deteriorating wound, fever, odour) 4. Ulcer localization; below the ankle 5. Signed Informed Consent
Exclusion criteria
1. Dry wound 2. Known allergy/hypersensitivity to the dressing 3. Treated with other Silver dressing on the ulcer target within 1 week prior to this investigation 4. Subjects who will have problems following the clinical investigation plan 5. Subjects enrolled in the investigation already 6. Subjects included in other ongoing clinical investigation at present or during the past 30 days. Subjects participating in a clinical sample investigation might be enrolled in the investigation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Signs and Symptoms of Local Infection | 4 weeks | Evaluation of signs of infection (exudate) from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levels of Pain in Connection to Dressing Changes. | 4 weeks | Levels of pain measured by VAS, visual analog scale. 1 to 100 mm, 1= low pain, 100= worse pain. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mepilex Transfer Ag An open, non-comparative study. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | Mepilex Transfer Ag |
|---|---|
| Age, Continuous | 61.1 years STANDARD_DEVIATION 12.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United Kingdom | 24 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 24 |
| serious Total, serious adverse events | 7 / 24 |
Outcome results
Primary
Changes in Signs and Symptoms of Local Infection
Evaluation of signs of infection (exudate) from baseline
Time frame: 4 weeks
Population: ITT
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mepilex Transfer Ag | Changes in Signs and Symptoms of Local Infection | Week 1 Exudate amount - worsening compared to base | 2 Participants |
| Mepilex Transfer Ag | Changes in Signs and Symptoms of Local Infection | Week 2 Exudate amount - worsening compared to base | 1 Participants |
| Mepilex Transfer Ag | Changes in Signs and Symptoms of Local Infection | Week 4 Exudate amount - worsening compared to base | 0 Participants |
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.
Time frame: 4 weeks
Population: For some patients pain assessment was not performed at all predefined timepoints. Therefore some data were not collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepilex Transfer Ag | Levels of Pain in Connection to Dressing Changes. | Baseline | 16 units on a scale | Standard Deviation 24.4 |
| Mepilex Transfer Ag | Levels of Pain in Connection to Dressing Changes. | Week 1 | 7.2 units on a scale | Standard Deviation 14.3 |
| Mepilex Transfer Ag | Levels of Pain in Connection to Dressing Changes. | Week 2 | 3.5 units on a scale | Standard Deviation 4.9 |
| Mepilex Transfer Ag | Levels of Pain in Connection to Dressing Changes. | Week 3 | 4.7 units on a scale | Standard Deviation 9.8 |
| Mepilex Transfer Ag | Levels of Pain in Connection to Dressing Changes. | Week 4 | 3.0 units on a scale | Standard Deviation 4.1 |