Diabetic Foot Ulcers
Conditions
Brief summary
The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of fast gelling dressing when used as intended in Diabetic Foot Ulcer (DFU). The primary endpoint will be Changes from baseline in the condition of the peri-wound skin measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin
Interventions
DEVICEFast gelling dressing
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. Texas Grade A1 or 2, C1 or 2 4. Exuding diabetic foot ulcer 5. Ulcer localisation; below the ankle 6. Signed Informed Consent.
Exclusion criteria
1. Known allergy/hypersensitivity to the dressing. 2. HbA1c ≥ 10% (86 mmol/mol) (most recent value within 3 months) 3. Wound infection requiring systemic treatment 4. Subjects who will have problems following the protocol. 5. Subjects included in other ongoing clinical investigation at present or during the past 30 days. 6. Toe pressure less than 70 mmHg 7. Clinical suspicion of osteomyelitis (based on probe to bone/radiological changes) 8. Dry wounds
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peri-wound Skin | 12 weeks | Measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fast Gelling Dressing Fast gelling dressing | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Fast Gelling Dressing |
|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 12.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 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 | 21 Participants |
| Region of Enrollment United Kingdom | 21 participants |
| Sex: Female, Male Female | 0 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 / 21 |
| serious Total, serious adverse events | 2 / 21 |
Outcome results
Primary
Change in Peri-wound Skin
Measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin
Time frame: 12 weeks
Population: number of patients with healthy/intact peri-wound skin that increased from baseline to final visit. (From 6 to 14)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fast Gelling Dressing | Change in Peri-wound Skin | 8 participants |