Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/09/2014
Date assigned
07/10/2014
Last edited
07/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sicco Bus

ORCID ID

Contact details

Zilvermeeuw 1
Almelo
7609PP
Netherlands
s.a.bus@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2-EUR-II-2=60

Study information

Scientific title

The efficacy of removable offloading devices to heal plantar forefoot ulcers in diabetes: a multicenter randomized controlled trial

Acronym

OFFLOAD

Study hypothesis

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 patient’s 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

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

Study design

Randomized controlled trial, parallel design of three study arms

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 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

Overall trial start date

23/11/2004

Overall trial end date

31/07/2014

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

23/11/2004

Recruitment end date

31/07/2014

Locations

Countries of recruitment

Germany, Netherlands

Trial participating centre

Zilvermeeuw 1
Almelo
7609PP
Netherlands

Sponsor information

Organisation

Euregio (Germany)

Sponsor details

Enscheder Straße 362
Gronau
D-48599
Germany
+49 (0)53-4605151
p.brugman@euregio.de

Sponsor type

Government

Website

http://www.euregio.eu

Funders

Funder type

Government

Funder name

Euregio Interreg IIIA program, project 2-EUR-II-2=60 “Diabetes FuB” (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes