Diabetic Ulcers on Both Feet
Conditions
Keywords
Diabetic Foot, Foot, Diabetic, Foot Ulcer, Diabetic, Feet, Diabetic
Brief summary
Diabetic foot ulcers are the complication of diabetes most frequently requiring hospitalization and carry very high treatment costs. Ulcers that fail to heal may lead to amputation of the foot or leg, causing permanent disability and major loss of working capacity. Neuropathy, vasculopathy and infection are the principal drivers of ulcer formation, and the bacteria encountered in these ulcers frequently show high antibiotic resistance. Locally acting wound care products are therefore of considerable importance. Silver has been used in wound treatment since antiquity. Silver nanoparticles have broad antibacterial, antifungal and antiviral properties: they can penetrate bacterial cell walls, alter membrane structure, increase membrane permeability, generate reactive oxygen species and release silver ions that inhibit deoxyribonucleic acid replication, and may result in cell death. Nanotechnologically produced silver products are thought to achieve greater tissue penetration and anti-infective activity, which is also relevant to the biofilm layer formed by bacteria, a recognised barrier to healing that is highly resistant to conventional antimicrobial therapy. This study evaluates the effects of a nanotechnologically produced, Turkish-manufactured silver-coated wound care dressing in diabetic foot ulcers, compared with conventional dressing using sterile saline-moistened gauze. Participants with a PEDIS grade 2 or grade 3 diabetic foot ulcer are allocated to the investigational dressing or to the conventional dressing. All participants receive routine diabetic foot care in addition to the assigned dressing. Wounds are assessed on days 0, 3, 7 and 21 by wound measurement, deep tissue culture and histopathological examination of tissue obtained at debridement.
Interventions
DEVICENanotechnological silver-coated wound dressing
Sterile, single-layer, non-adherent, flexible, silver-coated polyester dressing for topical use. Silver release over 7 days: 1 ppm. Silver content on the product: 160 mg/100 cm². May remain on the wound for up to 7 days and may be changed more frequently if required; in this study it is changed at 3-day intervals and applied for a total of 21 days.
OTHERSterile saline-moistened gauze dressing
Conventional wound treatment method described in the literature: sterile gauze impregnated with sterile physiological saline, changed daily and applied for a total of 21 days.
Sponsors
Ankara City Hospital Bilkent
ARGEN Medical and Health Products Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two parallel groups. Participants with a PEDIS grade 2 or grade 3 diabetic foot ulcer are assigned either to the investigational silver-coated dressing group or to the conventional saline-moistened gauze dressing group. All participants receive routine diabetic foot care in both groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged over 18 years * Able and willing to give written informed consent * PEDIS grade 2 or PEDIS grade 3 diabetic foot ulcer on either foot
Exclusion criteria
* Aged under 18 years * Known allergy to silver or to polyester * Pregnancy * Non-infected PEDIS grade 1 ulcer * PEDIS grade 4 ulcer, on the grounds of metabolic instability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in wound surface area | Day 0 (baseline), Day 3, Day 7 and Day 21 | Wound dimensions are measured at each assessment visit and wound surface area (cm²) is derived. The change from baseline and the time to wound closure are compared between the investigational dressing group and the control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological findings on deep tissue culture | Day 0, Day 3, Day 7 and Day 21 | Deep tissue culture is obtained after debridement at each assessment. Culture positivity and identified organisms are compared between the two groups as a measure of local infection control. |
| Change in PEDIS grade | Day 0, Day 3, Day 7 and Day 21 | Wound staging is performed with the PEDIS classification and change in grade is compared between the two groups. |
Countries
Turkey (Türkiye)
Outcome results
None listed