Offloading ulcers of the forefoot in patients with diabetes mellitus: a comparison between three removable treatment devices
| ISRCTN | ISRCTN89989776 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89989776 |
| Secondary identifying numbers | 2-EUR-II-2=60 |
- Submission date
- 10/09/2014
- Registration date
- 07/10/2014
- Last edited
- 21/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
People with diabetes are prone to foot ulcers. This is due to peripheral neuropathy (where slightly higher blood glucose levels have damaged nerves in the foot leading to numbness) and peripheral arterial disease (where fatty deposits have led to narrowing of the arteries and a reduced blood flow to the foot). These foot ulcers are potentially very serious, as they can result in infection and, in the worst cases, amputation. Treating the condition involves relieving the pressure on the foot, commonly known as offloading, and this can be achieved in a number of ways. We are going to compare the performance of three different but commonly used offloading devices: a removable total contact cast boot, a cast shoe, and a prefabricated forefoot offloading shoe.
Who can participate?
Adults aged between 18 and 85, with diabetes and a foot ulcer.
What does the study involve?
Patients are randomly allocated into one of three groups. Those in group 1 are treated with the cast boot. Those in group 2 are treated with a cast shoe. Those in group 3 are treated with a prefabricated forefoot offloading shoe. Their progress is then monitored until their ulcer heals or for up to a maximum of 20 weeks.
What are the possible benefits and risks of participating?
The benefit of the study for the patients participating is that their ulcers are treated with devices commonly used in clinical practice. There are no known risks related to participation, as each of the devices has been tested in everyday practice.
Where is the study run from?
The study is run from several collaborating medical centers in the Netherlands and Germany, with the Hospital Group Twente in Almelo being the lead center. Other participating centers are: Mathias Spital in Rheine, Germany and Hospital Group Twente in Hengelo, Medisch Spectrum Twente in Enschede, and Scheper Hospital in Emmen, in the Netherlands.
When is the study starting and how long is it expected to run for?
November 2004 to July 2014.
Who is funding the study?
Euregio Interreg IIIA program (Germany).
Who is the main contact?
Dr Sicco Bus
s.a.bus@amc.uva.nl
Contact information
Scientific
Zilvermeeuw 1
Almelo
7609PP
Netherlands
| s.a.bus@amc.uva.nl |
Study information
| Study design | Randomized controlled trial, parallel design of three study arms |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The efficacy of removable offloading devices to heal plantar forefoot ulcers in diabetes: a multicenter randomized controlled trial |
| Study acronym | OFFLOAD |
| Study objectives | 1. Percentage of healed plantar forefoot ulcers at 12 weeks is not significantly different between the MABAL cast shoe and the bivalved total contact cast and significantly higher in both these conditions when compared with the forefoot offloading shoe 2. Percentage of healed plantar forefoot ulcers at 20 weeks is not significantly different between the MABAL cast shoe and the bivalved total contact cast and significantly higher in both these conditions when compared with the forefoot offloading shoe 3. Time to complete healing is not significantly different between the MABAL shoe and the bivalved total contact cast and significantly shorter in both these conditions when compared with the forefoot offloading shoe 4. Peak plantar pressure reduction at the ulcer site compared to the patients own footwear is not significantly different between the MABAL cast shoe and the bivalved total contact cast and significantly larger in both these conditions when compared with the forefoot offloading shoe 5. Daily activity level is not significantly different between the MABAL cast shoe and the forefoot offloading shoe and significantly higher in both these conditions when compared with the bivalved total contact cast 6. Quality of life index is not significantly different between the MABAL cast shoe and the forefoot offloading shoe and significantly higher in both these conditions when compared with the bivalved total contact cast. 7. Complication rate is not significantly different between the MABAL cast shoe and the forefoot offloading shoe and significantly lower in both these conditions when compared with the bivalved total contact cast 8. Total treatment costs are not significantly different between the three conditions |
| Ethics approval(s) | Medical Ethical Comittee Twente, first approval: 08/07/2004, ref. METC/04327.bus Medical Ethical Comittee Twente, approval of amendment: 17/01/2012, ref. METC/12033.bus |
| Health condition(s) or problem(s) studied | Diabetes mellitus |
| Intervention | 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 2. MABAL cast shoe, removable fiberglass cast shoe, custom-made, one application, 20 weeks follow-up 3. Forefoot offloading shoe, removable, Rattenhuber Talus II, prefabricated, one application, 20 weeks follow-up |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 outcome measures | 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 patients 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 |
| Overall study start date | 23/11/2004 |
| Completion date | 31/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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) |
| Key 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 (< 6 weeks prior to study inclusion) 5. Progressive renal dysfunction (clearing <30ml/min or creatinine level >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 |
| Date of first enrolment | 23/11/2004 |
| Date of final enrolment | 31/07/2014 |
Locations
Countries of recruitment
- Germany
- Netherlands
Study participating centre
7609PP
Netherlands
Sponsor information
Government
Enscheder Straße 362
Gronau
D-48599
Germany
| Phone | +49 (0)53-4605151 |
|---|---|
| p.brugman@euregio.de | |
| Website | http://www.euregio.eu |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results of the differences in cumulative plantar tissue stress between healing and non-healing plantar neuropathic diabetic foot ulcers, | 01/03/2018 | 21/01/2019 | Yes | No |
| Results article | results of the efficacy of removable devices to offload and heal neuropathic plantar forefoot ulcers in people with diabetes, | 01/02/2018 | 21/01/2019 | Yes | No |
Editorial Notes
21/01/2019: Publication references added
