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Diabetic FootNCT02995863

This Research Hypothesizes That the Use of a Rigid Rocker Sole Reduces the Recurrence Rate of Diabetic Foot Ulcers in Patients With Peripheral Neuropathy.

A study testing Rigid Rocker Sole Footwear and Therapeutic Footwear in people with Diabetic Foot and Diabetic Foot Ulcer, run by Universidad Complutense de Madrid at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research presents a randomized clinical trial which analyzes the efficacy of a rigid rocker sole in the reduction of the recurrence rate of plantar ulcers in diabetic foot patients. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetic Foot, Diabetic Foot Ulcer
What is being tested?
Rigid Rocker Sole Footwear and Therapeutic Footwear
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteSpain
Study dates
10 Dec 2016to 10 May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Type 1 or 2 diabetic patients regardless of the pharmacotherapy that they receive.
  • Adult patients of both sexes.
  • Peripheral neuropathy patients.
  • Patients without wounds or ulcers at the examination time.
  • Patients with a foot ulcers history.
  • Patients with or without minor amputation prior to the inclusion time in the present study.
  • Patients who don´t need gait support mechanisms such as walking sticks, crutches, splints or any other devices which interferes with the autonomous development of the gait.

Who cannot join

  • Patients with mayor amputation.
  • Patients with rheumatic disease that affect the feet.
  • Patients with peripheral neuropathy of different etiology to Diabetes mellitus.
  • Patients with several critical ischemia criteria, defined by TACS II guideline.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Clínica Universitaria de Podología de la Universidad Complutense de Madrid

    Madrid, 28040

Other trials in Spain

About this study

Official title: Clinical Efficacy of Therapeutic Footwear With a Rigid Rocker Sole in the Prevention of Reulceration in Patients With Diabetes Mellitus and Diabetic Polineuropathy: a Prospective and Randomized Clinical Trial.

This research presents a randomized clinical trial which analyzes the efficacy of a rigid rocker sole in the reduction of the recurrence rate of plantar ulcers in diabetic foot patients. The hypothesis of the research is the use of a rigid rocker sole reduces the recurrence rate of diabetic foot ulcers in patients with peripheral neuropathy.

Being tested
Rigid Rocker Sole Footwear, Therapeutic Footwear
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rigid Rocker Sole FootwearDevice

  • Therapeutic FootwearDevice

Study groups in NCT02995863
Study groupRoleWhat they receive
Experimental GroupExperimentalRigid rocker sole footwear
Receives: Device: Rigid Rocker Sole Footwear
Control GroupActive comparatorTherapeutic footwear
Receives: Device: Therapeutic Footwear

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of diabetic foot ulcer

    The Wagner system assesses ulcer depth and the presence of osteomyelitis or gangrene using the following grades: grade 0 (pre- or post-ulcerative lesion), grade 1 (partial/full-thickness ulcer), grade 2 (probing to tendon or capsule), grade 3 (deep with osteitis), grade 4 (partial foot gangrene) and grade 5 (whole foot gangrene

    Measured: through study completion, an average of 6 months

Secondary outcomes (10)
  1. Ankle Joint movility

    The ankle joint is examined in the neutral position, with the patient prone; a vertical line is marked on the patient's skin from heel to midcalf, and the maxi- mum range of dorsiflexion in passive motion is mea- sured in degrees with a goniometer. The normal value for the ankle joint is a mobility >90° of dorsi- flexion.

    Measured: through study completion, an average of 6 months

  2. Mobility of the First metatarsal Joint

    Is examined with the patient in the supine position, and a horizontal line is drawn from the big toe to the heel. The maximum range of pas- sive dorsiflexion is recorded. The normal range of joint mobility is >65° at rest and 30° when the patient is standing.

    Measured: through study completion, an average of 6 months

  3. Subtalar Joint Movements

    (inversion and eversion) are examined with the patient in a prone position, holding the calcaneus with one hand and the neck of the astragalus with the thumb and index finger of the other hand. Holding the astragalus rather than the tibia isolated the s

    Measured: through study completion, an average of 6 months

  4. IPAQ (International Physical Activity Questionnaires)

    The purpose of the International Physical Activity Questionnaires (IPAQ) is to provide a set of well-developed instruments that can be used internationally to obtain comparable estimates of physical activity. There are two versions of the questionnaire. The short version is suitable for use in national and regional surveillance systems and the long version provide more detailed information often required in research work or for evaluation purposes.

    Measured: through study completion, an average of 6 months

  5. Foot Type

    The validated protocol of the Foot Posture Index-6 involves the rating of three criteria in the rearfoot: Talar head palpation,Supra- and infra-lateral malleolar curvature and Calcaneal frontal plane position. In addition, there are three criteria on the forefoot: Prominence in the region of the talonavicular joint (TNJ), Congruence of the medial longitudinal arch (MLA), Abduction/adduction of the forefoot on the rearfoot. Each item is graded by a five-point Likert-type, from -2 to +2: 0 for neutral, with a minimum score of -2 for clear signs of supination, and +2 for positive signs of pronation. The final FPI-6 score will be a whole number between -12 and +12. A total FPI-6 score between 0 and +5 indicates a neutral foot, a score of above +6 indicates a pronated or highly pronated foot, and a score between -1 and -12 indicates a supinated or highly supinated foot.

    Measured: through study completion, an average of 6 months

  6. Deformities

    Forefoot deformities were considered when the foot presented any of the following: hallux valgus, Tailor's bunion; toe contractures (hammer-toe, claw-toe or mallet-toe deformities); subluxation or dislocation of the metatarsophalangeal joints (overlapped toe and prominent metatarsal heads).

    Measured: through study completion, an average of 6 months

  7. Ankle - Brachial Index (ABI)

    Were assessed by the same experienced podiatrist using a manual 8 MHz Doppler (Doppler II, Huntleigh Healthcare Ltd, South Glamorgan, UK), and the toe systolic pressure was taken with a digital plethysmography (Systoe, Atys Medical, Quermed, Madrid). The dorsalis pedis artery was used for recording ankle values. The ABI were calculated with the equations of the ankle pressure readings divided by the highest brachial reading between the right and left arms. We considered Peripheral Arterial Disease to have an ABI value less than 0.9; normal ABI values were between 0.9 and 1.39, and an ABI value ≥1.4 was considered poorly compressible vessels related to medial arterial calcification in distal arteries.

    Measured: through study completion, an average of 6 months

  8. Sensorimotor neuropathy

    Sensorimotor neuropathy was diagnosed by evaluation using a Semmes-Weinstein 5.07/10 g monofilament and a biothesiometer (both from Novalab Iberica, Madrid, Spain). Patients who did not feel 1 of the 2 tests were diagnosed with neuropathy.

    Measured: through study completion, an average of 6 months

  9. Physical Activity Questionnaire

    Measurements about time of use of footwear either at home or outdoor. Normal value ranges are: never, 1 day per week, 1 to 3 day per week, 4 to 5 days per week and 6 to 7 days per week.

    And measurements about how many hours per day the patient wear the footwear, the normal value ranges are: less than 1 hour, 1 to 3 hours per day, 4 to 7 hours per day, 8 to 11 hours per day and more than 12 hours per day.

    Measured: through study completion, an average of 6 months

  10. Toe - Brachial Index (TBI)

    Were assessed by the same experienced podiatrist using a manual 8 MHz Doppler (Doppler II, Huntleigh Healthcare Ltd, South Glamorgan, UK), and the toe systolic pressure was taken with a digital plethysmography (Systoe, Atys Medical, Quermed, Madrid). The ABI and the TBI were calculated with the equations of the ankle or toe pressure readings divided by the highest brachial reading between the right and left arms. We considered PAD to have a TBI value less than 0.7; normal TBI values were between 0.7 and 0.99, and TBI ≥ 1 was considered distal arteries calcification.

    Measured: through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2016 (estimated)
  2. Study start10 Dec 2016
  3. Primary completion10 Dec 2017
  4. Study completion10 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02995863
Sponsor's protocol ID
UComplutenseMadrid
Status last verified
May 2018
First submitted
12 Dec 2016
Last updated
16 May 2018
Results posted
No

Publications

  • Lopez-Moral M, Lazaro-Martinez JL, Garcia-Morales E, Garcia-Alvarez Y, Alvaro-Afonso FJ, Molines-Barroso RJ. Clinical efficacy of therapeutic footwear with a rigid rocker sole in the prevention of recurrence in patients with diabetes mellitus and diabetic polineuropathy: A randomized clinical trial. PLoS One. 2019 Jul 11;14(7):e0219537. doi: 10.1371/journal.pone.0219537. eCollection 2019.

    PubMed 31295292

Questions about this trial

What is this clinical trial studying?

A study testing Rigid Rocker Sole Footwear and Therapeutic Footwear in people with Diabetic Foot and Diabetic Foot Ulcer, run by Universidad Complutense de Madrid at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of diabetic foot ulcer (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02995863, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.

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