Specialty: Diabetes, Primary sub-specialty: Both
Conditions
Interventions
Following written consent, participants are observed for two weeks to establish healing rate. At the end of two weeks, patients are only eligible for the intervention phase if their wound has healed <
Sponsors
Cumbria Partnership NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of Diabetic Foot Ulcer (DFU), present on plantar or calcaneus area 2. DFU present for at least 2 weeks. 3. Adult patients aged > 18 years 4. Patients with recurrent wounds, including multiple wounds, are eligible. The largest of the wounds, in plantar or calcaneus area, will be selected for the trial. 5. Patients who have undergone an episode of infection prior to the enrolment but are not currently receiving antibiotic therapy or antimicrobial dressings for the DFU in question are eligible – i.e. where a previous infection has resolved. 6. Mental capacity to give consent
Exclusion criteria
Exclusion criteria: 1. Under the age of 18 years 2. Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity 3. Limited life expectancy, i.e. undergoing palliative care 4. Active infection in DFU 5. Systemic antibiotic treatment 6. Any personal objection to being administered a product containing porcine material. 7. Patients who are participating in another research study involving an investigational product. 8. The patient has concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives, including alcohol or drug dependency. 9. DFU in other area of the foot (e.g. in between toes, which would make exact ulcer size measurement impossible) 10. Patient pregnant or lactating 11. Ankle brachial index < 0.5, measured within 3 months of baseline visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of the Granulox spray in terms of wound healing is assessed using the DFU size, measured with Convatec grid tool at -2 weeks (two weeks observation), baseline, week three, six nine and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Size and characteristics of DFU is measured using the PUSH score at -2 weeks (two weeks observation), baseline, week three, six nine and 12 2. Grading of DFU is assessed using Texas Univ grading score at -2 weeks (two weeks observation), baseline, week three, six nine and 12 3. Wound closure status is assesed as either open or closed by clinician at baseline, week three, six, nine and 12 4. Patient mobility score is measured using the LifeSpace questionnaire at baseline, week six and 12 5. Pain related to DFU is measured using the Visual Analogue Pain score at -2 weeks (two weeks observation), baseline, week three, six nine and 12 6. General Quality of life score is measured using the EQ5D-5L and wound-related quality of life score as measured by Charing Cross Venous Ulcer Questionnaire at baseline, week six and 12 7. Wound status check [healed, not healed, recurrence] and any incidences of adverse events at week 18 8. Patient withdrawal rates due to change in management (e.g. need for surgery) | — |
Countries
England, United Kingdom
Contacts
Public ContactLeon Jonker
Outcome results
None listed