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Removable Walker for Neuropathic Ulcers

Primary Purpose

Diabetic Foot

Status

Completed

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

non-removable fiberglass

Stabil-D®

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring diabetic foot, neuropathic plantar ulcer, ulcer healing, non-removable total contact cast, removable cast walker

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The presence of neuropathic plantar ulcer with an area graded IA according to the Texas University classification, AND
The presence of peripheral neuropathy. Peripheral neuropathy was diagnosed based on insensitivity to a 10-g Semmes-Weinstein monofilament in more than 6 out of 9 areas of the foot and by a vibration perception threshold measured by biothesiometer (Neurothesiometer SLS, Nottingham, UK) at the malleolus > 25 volts.

Exclusion Criteria:

Presence of an ankle-brachial pressure index (ABI) < 0.9 and/or transcutaneous oxygen tension (TcPO2) < 50 mmHg tested on the dorsum of the foot,
Presence of clinical signs of infection, including edema, erythema, increased local skin temperature, or drainage,
The probe-to-bone maneuver was required to be negative,
Tthe standard X-ray examination of the foot was required to be negative for osteomyelitis,
Use of steroids or cytostatic drugs,
Presence of sensory, motor, or visual problems that could impair functional autonomy,
Active ulcer on the contralateral foot,
Previous major amputation of the contralateral limb,
Previous or current deep venous leg thrombosis, OR
Mental disorders interfering with patient compliance.

Sites / Locations

Diabetic Foot Center - IRCCS Multimedica

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

non-removable fiberglass

Stabil-D®

Arm Description

Softcast3M®, 3M Health Care, St. Paul, MN (USA) were used for construction of the pressure-relief apparatus

Composed of a specifically designed rigid, boat shaped, and fully rocker bottom sole

Outcomes

Primary Outcome Measures

Decrease in ulcer size

Secondary Outcome Measures

Complete healing rate at the end of the study

Full Information

NCT ID

NCT01005264

First Posted

October 19, 2009

Last Updated

October 29, 2009

Sponsor

IRCCS Multimedica

1. Study Identification

Unique Protocol Identification Number

NCT01005264

Brief Title

Removable Walker for Neuropathic Ulcers

Official Title

Effectiveness of Removable Walker Cast Versus Non-removable Fiberglass Off-bearing Cast in the Healing of Diabetic Plantar Foot Ulcer- a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

IRCCS Multimedica

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Objective: To evaluate the efficacy of removable cast walker compared to non-removable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer Research design and methods: Forty-five adult diabetic patients with non-ischemic, non-infected neuropathic plantar ulcer were randomized to treatment with a non-removable fiberglass off-bearing cast (TCC group) or walker cast (Stabil-D group). Treatment duration was 90 days. Percent reduction in ulcer surface area and total healing rates were evaluated after treatment.

Detailed Description

Study design: Two centers specializing in diabetic foot management (located in Sesto S. Giovanni and Milan, Italy) participated to this open, randomized clinical trial. The ethics-committee approved the study on January 10th, 2008. Enrollment of consecutive patients began February 2008 and ended March 2009. Eligible patients were fully informed of the study aim and procedures and written consent was obtained prior to study participation. Patients were then randomly assigned to one of the two treatment groups by opening randomization codebreak envelopes containing one of the two options. Separate randomization was performed for each center, and a copy of all randomization envelopes was kept at the statistical department of the Multimedica center. The two arms were composed of patients managed with non-removable fiberglass off-bearing cast (TCC group) and patients offloaded with the Stabil-D® (Podartis srl, Montebelluna, Treviso, Italy) walker cast (Stabil-D group).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot

Keywords

diabetic foot, neuropathic plantar ulcer, ulcer healing, non-removable total contact cast, removable cast walker

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

non-removable fiberglass

Arm Type

Active Comparator

Arm Description

Softcast3M®, 3M Health Care, St. Paul, MN (USA) were used for construction of the pressure-relief apparatus

Arm Title

Stabil-D®

Arm Type

Active Comparator

Arm Description

Composed of a specifically designed rigid, boat shaped, and fully rocker bottom sole

Intervention Type

Device

Intervention Name(s)

non-removable fiberglass

Other Intervention Name(s)

Softcast3M®, 3M Health Care, St. Paul, MN (USA)

Intervention Description

Two types of fiberglass bandages (Softcast3M®, 3M Health Care, St. Paul, MN (USA)) were used for construction of the pressure-relief apparatus

Intervention Type

Device

Intervention Name(s)

Stabil-D®

Other Intervention Name(s)

Podartis srl, Montebelluna, Treviso, Italy

Intervention Description

Stabil-D Stabil-D® is composed of a specifically designed rigid, boat shaped, and rocker sole

Primary Outcome Measure Information:

Title

Decrease in ulcer size

Time Frame

at 90th day

Secondary Outcome Measure Information:

Title

Complete healing rate at the end of the study

Time Frame

at 90th day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The presence of neuropathic plantar ulcer with an area graded IA according to the Texas University classification, AND The presence of peripheral neuropathy. Peripheral neuropathy was diagnosed based on insensitivity to a 10-g Semmes-Weinstein monofilament in more than 6 out of 9 areas of the foot and by a vibration perception threshold measured by biothesiometer (Neurothesiometer SLS, Nottingham, UK) at the malleolus > 25 volts. Exclusion Criteria: Presence of an ankle-brachial pressure index (ABI) < 0.9 and/or transcutaneous oxygen tension (TcPO2) < 50 mmHg tested on the dorsum of the foot, Presence of clinical signs of infection, including edema, erythema, increased local skin temperature, or drainage, The probe-to-bone maneuver was required to be negative, Tthe standard X-ray examination of the foot was required to be negative for osteomyelitis, Use of steroids or cytostatic drugs, Presence of sensory, motor, or visual problems that could impair functional autonomy, Active ulcer on the contralateral foot, Previous major amputation of the contralateral limb, Previous or current deep venous leg thrombosis, OR Mental disorders interfering with patient compliance.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ezio Faglia, MD

Organizational Affiliation

Diabetic Foot Center - IRCCS Multimedica, Sesto San Giovanni (Milan), Italy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Diabetic Foot Center - IRCCS Multimedica

City

Sesto San Giovanni

State/Province

Milan

ZIP/Postal Code

20099

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

17563333

Citation

Caravaggi C, Sganzaroli A, Fabbi M, Cavaiani P, Pogliaghi I, Ferraresi R, Capello F, Morabito A. Nonwindowed nonremovable fiberglass off-loading cast versus removable pneumatic cast (AircastXP Diabetic Walker) in the treatment of neuropathic noninfected plantar ulcers: a randomized prospective trial. Diabetes Care. 2007 Oct;30(10):2577-8. doi: 10.2337/dc07-0990. Epub 2007 Jun 11. No abstract available.

Results Reference

result

PubMed Identifier

17327325

Citation

Piaggesi A, Macchiarini S, Rizzo L, Palumbo F, Tedeschi A, Nobili LA, Leporati E, Scire V, Teobaldi I, Del Prato S. An off-the-shelf instant contact casting device for the management of diabetic foot ulcers: a randomized prospective trial versus traditional fiberglass cast. Diabetes Care. 2007 Mar;30(3):586-90. doi: 10.2337/dc06-1750.

Results Reference

result

PubMed Identifier

11128345

Citation

Caravaggi C, Faglia E, De Giglio R, Mantero M, Quarantiello A, Sommariva E, Gino M, Pritelli C, Morabito A. Effectiveness and safety of a nonremovable fiberglass off-bearing cast versus a therapeutic shoe in the treatment of neuropathic foot ulcers: a randomized study. Diabetes Care. 2000 Dec;23(12):1746-51. doi: 10.2337/diacare.23.12.1746.

Results Reference

result

PubMed Identifier

20357377

Citation

Faglia E, Caravaggi C, Clerici G, Sganzaroli A, Curci V, Vailati W, Simonetti D, Sommalvico F. Effectiveness of removable walker cast versus nonremovable fiberglass off-bearing cast in the healing of diabetic plantar foot ulcer: a randomized controlled trial. Diabetes Care. 2010 Jul;33(7):1419-23. doi: 10.2337/dc09-1708. Epub 2010 Mar 31.

Results Reference

derived

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Removable Walker for Neuropathic Ulcers

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