Diabetic Foot UlcerNCT03725917
Patients With Diabetic Neuropathy Who Receive Physiotherapy Treatment Will Have a Decrease in Diabetic Foot Ulcers
A study testing Physiotherapy protocol in people with Diabetic Foot Ulcer and Diabetic Neuropathy Peripheral, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
This study evaluates the effects of a physiotherapy protocol (manual therapy and exercise) in the prevention of diabetic foot ulcers in patients with diabetic neuropathy. A group of participants will receive a physiotherapy protocol added to their usual medical treatment and the other group will not receive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetic Neuropathy Peripheral
- What is being tested?
- Physiotherapy protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteSpain
- Study dates
- 25 Mar 2019to 1 Dec 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with diabetes mellitus type 1 or type 2
- Patients with diabetic neuropathy
- Patients with no previous history of ulcers
- Patients with no previous history of lower limb amputations
Who cannot join
- Patients with neurological or orthopedic problems that make walking difficult (spasticity, cerebral palsy, poliomyelitis, rheumatoid arthritis)
- Severe vascular complications (arterial or venous ulcers)
- Patients with critical ischemia
- Patient who need walking aids (canes, crutches, splints etc.)
- Patients with a history of neuropathy with different etiology from diabetes mellitus.
- Patients with peripheral nervous lesions (traumatic origin, associated with surgical procedures, compression of spinal roots, plexus palsy, herpes zoster, polyradiculopathy, etc.)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Complutense de Madrid
Madrid, Madrid, 28400
Guido F Gómez Chiguano, Physiotherapist, 655878395, guidogom@ucm.es
About this study
Official title: Efficacy of a Protocol of Intervention in Physiotherapy in the Prevention of Diabetic Foot Ulcers in Patients With Diabetic Neuropathy
This study evaluates the effects of a physiotherapy protocol (manual therapy and exercise) in the prevention of diabetic foot ulcers in patients with diabetic neuropathy. A group of participants will receive a physiotherapy protocol added to their usual medical treatment and the other group will not receive physiotherapy treatment.
Read the detailed description
Neuropathic diabetic patients present alterations in joint mobility, plantar pressures and ankle and foot function, characteristics related to the development of ulcers.
In previous studies, it has been observed that physiotherapy protocols have produced improvements in joint mobility, magnitude of plantar pressures, distribution of plantar pressures, and improved function in the ankle and foot.
A 12-week progressive physiotherapy protocol composed of manual therapy and exercise could produce changes in foot and ankle characteristics in diabetic neuropathic patients related to tissue damage, resulting in a reduction in ulcerations.
- Being tested
- Physiotherapy protocol
- Keywords
- Prevention, Physiotherapy, Diabetic Foot Ulcer, Exercise Therapy, Manual Therapy
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy protocolOther
Also called Physical therapy protocol
The intervention will consist of a physiotherapy protocol twice a week for twelve weeks. The protocol will be done in three phases, constituting each month, a phase of the protocol. The first two phases will include therapeutic exercise of progressive difficulty and manual therapy, while the last phase will include only one week of manual therapy and therapeutic exercise, the last three weeks being composed only of therapeutic exercise
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The intervention will be a progressive physiotherapy protocol formed by therapeutic exercise and manual therapy Receives: Other: Physiotherapy protocol |
| Control Group | No intervention | The control group will not receive physiotherapy treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the integrity of the skin (Ulceration)
An ulcer is considered a full thickness wound below the ankle in a diabetic patient, regardless of duration, including gangrene and necrosis.
The evaluator will review the patient's medical records on the day of the evaluations, in order to assess if there has been an ulceration in the periods between evaluations and also perform a foot exploration to assess if the ulcer is present on the day of measurement.
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: Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks
Secondary outcomes (6)
Change in maximum plantar pressure
The maximum plantar pressure of 10 areas of foot support (medial heel, lateral heel, midfoot, plantar area of each of the heads of the metatarsals from first to fifth, first toe and support area of the middle fingers from second to fifth) will be obtained through the F-Scan® system, a computerized pedobarographic analysis system. To express the maximum plantar pressure the newton per centimeter (N/cm) will be used.
Measured: Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks
Change in joint mobility
The mobility of the tibiofibular-talar joint, subtalar joint and the first metatarsophalangeal joint, both in loading and unloading, will be measured by goniometer.
Measured: Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks
Change in foot function index
The foot function index will be measured by adapting the Foot Function Index (FFI) Questionnaire to Spanish. The FFI is a questionnaire in which the answers are about the experience of the participant's previous week.
It consists of 23 items divided into 3 subscales: pain, disability and limitation of activity. For each item there is an visual analog scale with values from 0 to 10. If the respondents do not find the question appropriate, they can leave it blank. Once the questionnaire is completed, all the points are added and divided by the maximum score that can be achieved with the items that have been filled out. The result obtained from each subscale is multiplied by one hundred, and rounded if necessary, to obtain values between zero and one hundred, the higher the value, the worse the patient's condition will be. The total function is obtained by calculating the average of the 3 subscale
Measured: Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks
Change in neurological function of the foot
Neurological function of the foot will be assessed using the Neuropathy Disability Score (NDS) instrument. The neurological function of the foot will be assessed using the NDS instrument. This allows the global assessment of neuropathy, by evaluating both long nerve fibers, which intervene in reflexes and vibratory sensitivity; as short fibers, involved in sensitivity to pain and temperature. It consists of a standardized examination of ankle reflexes and the perception of some sensory tests: pain, temperature and vibration. The minimum score of the NDS is 0 and the maximum score is 10, 5 in each leg. A score of 10 points indicates the complete loss of sensitivity and the absence of tendon reflexes. An NDS score ≥ 6/10 has a 2.3 times higher risk of developing a new ulcer in a 2-year follow-up period than those with a score of ≤ 5/10
Measured: Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks
Change in confidence in the balance for specific activities
Confidence and balance in specific activities will be assessed by adapting the ´´Activities Specific Balance Confidence Scale (ABC)'' to Spanish.
The ABC scale is a 16-item questionnaire that assesses the level of confidence when performing a specific task without losing balance or becoming unstable. The score of each item varies between 0% (No confidence) and 100% (Total confidence). The final score is obtained by adding the value of each item, and dividing it by 16
Measured: Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks
Changes in the integral pressure-time
The integral pressure-time of 10 areas of foot support (medial heel, lateral heel, midfoot, plantar area of each of the heads of the metatarsals from first to fifth, first toe and support area of the middle fingers from second to fifth) will be obtained through the F-Scan® system, a computerized pedobarographic analysis system. To express the integral pressure-time the newton second per centimenter will be used (N.S/cm).
Measured: Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start25 Mar 2019
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Gomez Chiguano, Universidad Complutense de Madrid
- Investigators
- José L Lázaro Martínez, Study director, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725917
- Sponsor's protocol ID
- V2.0_16.07.18
- Status last verified
- Apr 2019
- First submitted
- 24 Oct 2018
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goldsmith JR, Lidtke RH, Shott S. The effects of range-of-motion therapy on the plantar pressures of patients with diabetes mellitus. J Am Podiatr Med Assoc. 2002 Oct;92(9):483-90. doi: 10.7547/87507315-92-9-483.
PubMed 12381797Cerrahoglu L, Kosan U, Sirin TC, Ulusoy A. Range of Motion and Plantar Pressure Evaluation for the Effects of Self-Care Foot Exercises on Diabetic Patients with and Without Neuropathy. J Am Podiatr Med Assoc. 2016 May;106(3):189-200. doi: 10.7547/14-095.
PubMed 27269974Sartor CD, Hasue RH, Cacciari LP, Butugan MK, Watari R, Passaro AC, Giacomozzi C, Sacco IC. Effects of strengthening, stretching and functional training on foot function in patients with diabetic neuropathy: results of a randomized controlled trial. BMC Musculoskelet Disord. 2014 Apr 27;15:137. doi: 10.1186/1471-2474-15-137.
PubMed 24767584Dijs HM, Roofthooft JM, Driessens MF, De Bock PG, Jacobs C, Van Acker KL. Effect of physical therapy on limited joint mobility in the diabetic foot. A pilot study. J Am Podiatr Med Assoc. 2000 Mar;90(3):126-32. doi: 10.7547/87507315-90-3-126.
PubMed 10740995
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Protocol of Intervention in Physiotherapy in the Prevention of Diabetic Foot Ulcers in Patients With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT03725917
- Acronym / sponsor ID
- V2.0_16.07.18
- Keywords
- Prevention, Physiotherapy, Diabetic Foot Ulcer, Exercise Therapy, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effects of a physiotherapy protocol (manual therapy and exercise) in the prevention of diabetic foot ulcers in patients with diabetic neuropathy. A group of participants will receive a physiotherapy protocol added to their usual medical treatment and the other group will not receive physiotherapy treatment.
Detailed description
Neuropathic diabetic patients present alterations in joint mobility, plantar pressures and ankle and foot function, characteristics related to the development of ulcers.
In previous studies, it has been observed that physiotherapy protocols have produced improvements in joint mobility, magnitude of plantar pressures, distribution of plantar pressures, and improved function in the ankle and foot.
A 12-week progressive physiotherapy protocol composed of manual therapy and exercise could produce changes in foot and ankle characteristics in diabetic neuropathic patients related to tissue damage, resulting in a reduction in ulcerations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Physiotherapy protocolThe intervention will be a progressive physiotherapy protocol formed by therapeutic exercise and manual therapy |
| Control Group | No intervention | –The control group will not receive physiotherapy treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with diabetes mellitus type 1 or type 2
- Patients with diabetic neuropathy
- Patients with no previous history of ulcers
- Patients with no previous history of lower limb amputations
Key exclusion criteria (6 listed)
- Patients with neurological or orthopedic problems that make walking difficult (spasticity, cerebral palsy, poliomyelitis, rheumatoid arthritis)
- Severe vascular complications (arterial or venous ulcers)
- Patients with critical ischemia
- Patient who need walking aids (canes, crutches, splints etc.)
- Patients with a history of neuropathy with different etiology from diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy protocolAlso: Physical therapy protocolThe intervention will consist of a physiotherapy protocol twice a week for twelve weeks. The protocol will be done in three phases, constituting each month, a phase of the protocol. The first two phases will include therapeutic exercise of progressive difficulty and manual therapy, while the last phase will include only one week of manual therapy and therapeutic exercise, the last three weeks being composed only of therapeutic exercise | Other | Experimental Group |
Primary outcome
Change in the integrity of the skin (Ulceration)
Time frame: Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks
An ulcer is considered a full thickness wound below the ankle in a diabetic patient, regardless of duration, including gangrene and necrosis. The evaluator will review the patient's medical records on the day of the evaluations, in order to assess if there has been an ulceration in the periods between evaluations and also perform a foot exploration to assess if the ulcer is present on the day of measurement. 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).
6 secondary outcomes
Change in maximum plantar pressure
Time frame: Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks
Change in joint mobility
Time frame: Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks
Change in foot function index
Time frame: Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks
Change in neurological function of the foot
Time frame: Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks
Change in confidence in the balance for specific activities
Time frame: Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks
Changes in the integral pressure-time
Time frame: Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Background: PubMed 12381797Goldsmith JR, Lidtke RH, Shott S. The effects of range-of-motion therapy on the plantar pressures of patients with diabetes mellitus. J Am Podiatr Med Assoc. 2002 Oct;92(9):483-90. doi: 10.7547/87507315-92-9-483.
- Background: PubMed 27269974Cerrahoglu L, Kosan U, Sirin TC, Ulusoy A. Range of Motion and Plantar Pressure Evaluation for the Effects of Self-Care Foot Exercises on Diabetic Patients with and Without Neuropathy. J Am Podiatr Med Assoc. 2016 May;106(3):189-200. doi: 10.7547/14-095.
- Background: PubMed 24767584Sartor CD, Hasue RH, Cacciari LP, Butugan MK, Watari R, Passaro AC, Giacomozzi C, Sacco IC. Effects of strengthening, stretching and functional training on foot function in patients with diabetic neuropathy: results of a randomized controlled trial. BMC Musculoskelet Disord. 2014 Apr 27;15:137. doi: 10.1186/1471-2474-15-137.
- Background: PubMed 10740995Dijs HM, Roofthooft JM, Driessens MF, De Bock PG, Jacobs C, Van Acker KL. Effect of physical therapy on limited joint mobility in the diabetic foot. A pilot study. J Am Podiatr Med Assoc. 2000 Mar;90(3):126-32. doi: 10.7547/87507315-90-3-126.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José L Lázaro Martínez study director
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy protocol in people with Diabetic Foot Ulcer and Diabetic Neuropathy Peripheral, 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guido F Gómez Chiguano (+34 655878395, guido_101@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the integrity of the skin (Ulceration) (time frame: Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks). 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 NCT03725917, which also lists 4 linked publications.
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 24 Apr 2019.