Wondgenezing chronic wound Diabetic ulcer
Conditions
Interventions
3. Interventions:
All patients that are included will have surgical debridement of the wound at
the start of the study, preferably under local anaesthesia (Lidocaine 1%).
Surgical debridement is pe
Larval secretions
Larval therapy
Lucilia sericata
Wound healing
Sponsors
Chirurgie
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Diabetic patients with chronic wounds, defined in this study as a wound without any healing tendency within a period of 4 weeks, with sufficient arterial circulation (toe-brachial index > 0.7) ;- Mono- or bilateral lower extremity wound without healing tendency within 4 weeks after the initial injury/origin. - Wounds with at least 50% slough (yellow wound surface) or necrosis (black wound surface) - Wound surfaces from 10 up to 40 cm2 - Age >18 years - Classification: Wagner 1-3 / Texas AI-III and BI-III
Exclusion criteria
Exclusion criteria: - Use of immunosupressive medication - Other auto-immune diseases than Diabetes Mellitus - Malignancies (unless cured in the past) - Use of more than 4 units alcohol a day - Pregnancy/lactation - Classification: Wagner 0, 4-5, Texas A0, B0, C0-III and D0-III - Unable to understand dutch language - Unable to visit the hospital multiple times during a longer period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 4. Outcomes Primary outcome: 1. Does larval therapy accelerate wound healing? 2. Do single larval secretions accelerate wound healing? Photographs are taken with a ruler alongside the wound, and the wound surface in maximum length and maximum width will be measured at the start of the therapy, after week 1 and then every 2 weeks. If the wound has almost healed, photographs are taken every control, which is twice a week, to have more accurate final measurements and prevent bias in the primary outcome between the groups. To check the wound size, special software will be used for measurement (Canvas X). Measurement of wound sizes with a ruler tends to overestimate the sizes in larger and more irregularly shaped wounds, so digital measurement using software is adviced in literature. Closure of the wound surface is defined as a complete cover of the wound bed with an epithelial layer without a crusta (cicatricial tissue). One outcome assessor, who is blinded, will assess the results of the photographs without knowing which therapy was performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: 3. Is the bacterial load in the wound reduced during larval therapy or is the microbiome changed? Wound cultures will be taken at the start of the therapy, after week 1 and then every 2 weeks to investigate the bacterial species present in the wound, the bacterial load and their ability to form biofilms (microscopy). 4. Are there systemic immunological and/or anti-inflammatory effects of local larval application or larval secretion application? - Cytokines/complement will be measured in the wound fluid (e.g. C3d, C5b-C9, TNF*, IL-1, IL-6, IL-8, IL-10, PDGF, VEGF etc.). Wound fluid is collected by application of two sterile 5x5 cm gauzes (one packet) on the wound during 5 minutes in presence of 5 mL physiological saline, before start of the therapy, after the first and the third application and one week after the final application. -CRP, BSE, leukocytes and complement activity will be measured in serum before start of the therapy, after the first and the third application and one week after the final application. The HbA1c value will be measured once before start of the therapy. 5. Does moisture balance affect the time to wound healing? Moisture balance will be measured at the start of the therapy, after week 1 and then every 2 weeks (e.g. using WoundSense from www.ohmedics.com and/or observation by the caregiver) In chronic wounds with persistent inflammation, exudate production is out of balance. It is known that for wound bed preparation and physiological wound healing, moisture balance is important. Measurement of moisture balance can provide information about the effect of exudate production on the speed of wound healing. Furthermore, literature reports less pain in wounds with a moist environment, one of the other secondary outcomes, we will measure and correlate. 6. Is there a difference in reappearance of debris between the three groups? Reappearance of slough or necrotic tissue after initial surgical debrideme | — |
Countries
The Netherlands
Outcome results
None listed