1. The Ransart Boot Isabelle Dumont*, Eva Fernandez*, Marc Lepeut°. *Centre du Pied, Ransart, Belgique, °Centre Hospitalier de Roubaix, France.

2. Background and aims:  Diabetic neuropathic foot ulcers heal when offloaded.  Healing rate is higher with non-removable casts i.e. Total Contact Cast (TCC) than with removable ones i.e. R.C.W. (Removable Cast Walker), Scotch

3. Cast boot or Half shoe* even if the pressure on the ulcer is reduced in certain types of removable casts as much as in non-removable ones. Armstrong & al, Diabetes Care 24:1019-1022, 2001. Lavery & al, Diabetes Care 19:818-821, 1996. * Theory challenged by Nabuurs-Franssen & al, Diabetes Care 28:243- 247, 2005.

4.  Why? (This difference between removable and non-removable devices.)

5. Because of better compliance? Yes, obviously! But it is "forced" compliance… Ha Van & al, Diabetes Care, 26: 2848-2852, 2003.

6. But why are patients non-compliant? Not a lot of references to find….. Vileikyte L & al: Diabetes Metab Res Rev 2004;20(sup):S13-S18.

7. BUT patients are non-compliant even with non-removable casts…

8. Some patients failed to complete study with irremovable casts because of "discomfort/weight" of the device. Armstrong & al, Diabetes Care 28: 551-554, 2005. Some Quotations:

9. "The cast was too burdensome and interfered with daily activity". Complaints of difficulty with ambulation or sleeping were common in the TCC group. Mueller M. & al, Diabetes Care, 12: 384-388, 1989.

10.  Why? (This difference between removable and non-removable devices.)

11. Because of diminished activity? - Patients take + 60 % less steps when wearing a TCC than with Half-shoe. It is only a hypothesis. Not proven. Katz I. & al, Diabetes care, 28: 555-559, 2005. Armstrong D. & al, Diabetes care, 24: 1019-1022, 2001.

12. Patient activity does not imply ulcer activity especially with casts with windows. It seems obvious. BUT… It has to be proven.

13. Is forced diminished activity a reason for poor compliance?

14.  We have tried to build a removable cast to improve compliance and to allow normal daily activities while taking into account patients’ remarks about their casts and we have made a smaller, lighter and more discrete removable cast with a window: the Ransart boot.

15. Materials and methods: This is a preliminary study including: -11 diabetic patients (type I and II) -5 men, mean age: 56.1 + 11.6 years -mean HbA1c: 8.3 + 1.9 % -mean ulcer duration: 208 + 538 days -all neuropathic (VPT >25 V).

16.  Ulcer presentation: - 7 on the forefoot - 3 on the rear foot - 1 on the midfoot - 9 classed A1, 1 B1 and 1 B2 (Texas University Classification).

17.  Patients with PAD (non palpable pulses) and with osteomyelitis (probing to bone) were excluded.  For the included patients a Ransart boot was made.

18.  All patients received daily local care and were seen at our clinic every week.  They continued working, while wearing the boot, except for those obliged to wear security shoes or other special restrictions.

20. Time to build the boot + 30 min. Materials: - stockinette 1 or 2 rolls of Soft cast 1 roll of Scotch cast some Velcro

21. Results: The study is still on-going. Ten ulcers have healed. Mean time: 43.7 + 9.8 days. One ulcer is still active after 91 days - a B2 ulcer and the patient developped osteomyelitis.

22. No complications were recorded except, for 3 patients, skin abrasion on the instep which quickly healed after slight modification of the forefront of the boot.

23. PATIENTS1234567891011Mean +/- SD AGE (years)684969444857725335586556,1 +/- 11,6 years MAN (Y/N)YNNYYYNYNNN5M/6F TYPE 1 (Y/N)NNNYYYNNYNN7 TYPE 2/11 DIAB DURATION (years)452524154218 14238 18,2 +/- 10,9 years BMI 27,1 36.0 36,2 50,5 41,8 25,0 31,6 32,9 22,24032 34,1 +/- 8,1 RETINOPATHY (Y/N) Y NYYYYYYYYY10Y/11 NEUROPATHY (Y/N) Y Y Y Y Y Y Y Y Y Y Y 11Y/11 Hba1c (%)6,36,79,46,979,96,712,38,18,210,88,3 +/- 1,9 CREATININE (mg/dl) 1,9 0,9 1,8 1,7 1 1 1,3 0,8 0,7 1 1,3 1,2 +/- 0,4 mg/dl FOOT Characteristics 1 L toe amp 0 Charcot0 0 0 0 0 0 0 TEXAS CLASSA1 B2A1 B1 ULCER (days) DURATION 1422 21 1825 15 13 180 45 10 50 100 208 +/- 538 days ULCER LOCATION (under) 1st L metat Head 1st L metat head 5nd R metat head 3 + 4 R metat Head L midfoot L heel L heel 5nd L metat Head 4th R toe R heel 2nd R metat Head WINDOW DEPTH (mm) 18 15 161312159 14 11 15 1413,8 +/- 2,4 mm TIME TO HEAL (days) 423150not after 91days 3549406332504543,7 +/- 9,8 days 10pat/11 COMPLICATIONS (+) Skin abrasion + +0 0 0 0 +0 0 0 0

24. Conclusions :  The preliminary results are positive.  The role of diminished activity in healing rate is challenged by this tool.

25.  Further studies are needed to clarify the respective role of compliance (perhaps enhanced by a patient friendly cast?) and activity.

26.  Quality of life, level of activity, measured compliance, educational impact, costs and frequencies of recurrences are parameters that must be included in future studies. Thank you for any suggestions. isa.dumont@skynet.be