Diabetes mellitus Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants are randomly allocated into one of the following groups:
1. Total contact cast (bivalved), removable fiberglass cast, custom-made, one application, 20 weeks follow-up
Sponsors
Euregio (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >18 and <85 years old 2. Type 1 or 2 diabetes mellitus with HbA1c < 12% 3. Presence of a full thickness (i.e. extending through the dermis) neuropathic ulcer on the plantar forefoot (including the toes), ranging in size between 0.25 cm² and 25 cm² post debridement, which has been present for at least 2 weeks and is classified as University of Texas grade 1A or 2A 4. Peripheral neuropathy, defined according to the Diabetic Foot Ulcer Classification System for Research Purposes (PEDIS) from the International Working Group on the Diabetic Foot (IWGDF) 5. Wound bed free of all necrotic and infected soft and bony tissue as determined by clinical examination. X-ray films or semi-quantitative culture of the wound, if deemed necessary, will be performed 6. Ability and willingness to cooperate with the requirements of the study (e.g. able to speak, read and write German or Dutch, have home telephone, remain in the study area for 16 weeks, expect to be available for adverse event monitoring for the duration of the study, consent to randomization and offloading device provision)
Exclusion criteria
Exclusion criteria: 1. Known or suspected disease of the immune system 2. Systemic diseases, such as active rheumatoid arthritis 3. Current malignancy or connective tissue disease 4. Recent treatment with immunosuppressive or chemotherapeutic agents (300 umol/liter) or progressive worsening of renal function in the previous 6 months (> 20% per month) or severe nephrotic syndrome (>3 grams protein loss per day). In each of these conditions renal problems leading to dialysis is to be expected on short term basis 6. Additional ipsilateral ulcer on the plantar surface of the midfoot or heel 7. Presence of necrosis, purulence or sinus tracts in the wound that cannot be removed by debridement. 8. Circulation inadequate for healing in treated extremity, determined by an ankle/brachial pressure index (ABI) <0.8 or a toe systolic blood pressure <40 mmHg. 9. Clinical signs of infection, defined according to the Diabetic Foot Ulcer Classification System for Research Purposes (PEDIS) from the IWGDF 10. Severe foot deformity (i.e. any amputation other than the lesser toes, Charcot neuro-osteoarthropathy or equinus deformity). 11. Inability to walk unaided 12. Parallel participation in another intervention trial. 13. Use of antibiotics at randomization 14. Physical or mental conditions of which the patients? own physician feels they are, in the best interest of the patient, an exclusion for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer healing at 12 weeks. Healing is defined as complete wound closure (i.e. 100% epithelialization) without a need for a dressing and without any drainage present, with the wound remaining closed for at least 4 weeks after initial closure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ulcer healing at 20 weeks 2. Time to healing of the ulcer 3. Reduction in ulcer size in the first 4 weeks of treatment 4. Peak pressure at the ulcer site in the device 5. Peak pressure reduction at the ulcer site in the device, compared to patient?s own footwear 6. Cumulative stress at the ulcer site in the device 7. Number of daily foot steps 8. Adherence to treatment 9. Complication rate 10. Quality of life 11. Costs of treatment | — |
Countries
Germany, Netherlands
Outcome results
None listed