Diabetic Foot UlcerNCT06067022
Temporomandibular Dysfunction in Patients With Diabetic Foot Ulcers
An observational study of Diabetic Foot Ulcer and Temporomandibular Disorder, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study is to investigate the effects of the type, area and duration of ulceration on jaw pain, mandibular function limitation, TMD and swallowing in individuals with diabetic foot ulcers.The main questions it aims to answer are: Does the change in foot structure due to diabetic foot ulcer… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcer, Temporomandibular Disorder, Swallowing Disorder
- What is being tested?
- observation
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2023to 5 Jul 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Being over 18 years old
- Having been diagnosed with Type 2 diabetes for at least 10 years
- Not having a serious musculoskeletal, cardiac, neurological, etc. systemic disorder that may interfere with the research.
- Not having any communication problems
Who cannot join
- Having a diabetic foot ulcer
- Having a diagnosed psychiatric disease,
- Having had a temporomandibular joint operation,
- Having experienced direct or indirect trauma to the head-neck and spine area,
- Having had previous spine surgery,
- Having any mental problems,
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- Having a neuromuscular problem that proves a systemic specific pathological condition such as malignant condition of the spine and/or TMJ, fracture, rheumatoid disease,
- Having had facial paralysis less than 1 year ago,
- Being diagnosed with TMD,
- Having received TMJ-related physical therapy treatment in less than 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temporomandibular Dysfunction in Patients With Diabetic Foot Ulcers: What Could Be the Predictors?
The aim of this observational study is to investigate the effects of the type, area and duration of ulceration on jaw pain, mandibular function limitation, TMD and swallowing in individuals with diabetic foot ulcers.The main questions it aims to answer are:
- Does the change in foot structure due to diabetic foot ulcer have an effect on the temporomandibular jointand swalloving?
- What are the determinants of tempomandibular dysfunction in individuals with diabetic foot ulcers?
Participants (both groups) will be evaluated for quality of life, jaw functionality, mandibular dysfunction, oropharyngeal swallowing disorder, pain and diabetes complications.
Read the detailed description
The study was planned in an observational case-control study design. 84 participants were included. Individuals who signed the Informed Consent Form were included in the study. Individuals aged between 46-80 (min-max) who were diagnosed with type 2 DM and DFU in Harran University Research and Application Hospital Endocrinology Polyclinic were included in the study group, and healthy individuals aged 37-85 (min-max) without a diagnosis of DM were included in the control group. Among the exclusion criteria for all individuals from the study, the Mini-Mental Test score should be below 24, history of psychiatric illness, cancer, neurological problems, congenital anomalies, musculoskeletal problems, having a systemic disease, facial paralysis, undergoing surgery due to spine, abdomen and/or TMJ problem and receiving any treatment related to the spine and TMJ in less than 6 months.
In the clinical evaluation of individuals with DFU about diabetes and ulcers; diabetes duration, HbA1C value, glycemic control adequacy, and peripheral arterial disease were recorded, monofilament test was performed for sensory evaluation. Ulcer type and duration were recorded, and ulcer area was measured. Individuals' quality of life was evaluated with the Ferran Powers Quality of Life Index. In the evaluation of oral health in all participants; burning mouth syndrome, dry mouth sensation, tooth loss, tooth decay, and intraoral lesions were questioned.
Participants' pain reports were evaluated using the Numerical Rating Scale (NRS).
Participants' swallowing disorders were evaluated using the Eating Assessment Tool (EAT-10).
Participants' TMJ disorders were evaluated using the Fonseca Anamnestic Index.
Participants' mandibular dysfunctions were evaluated using the Mandibular Function Disorder Questionnaire .
- Being tested
- observation
- Keywords
- Diabetes Mellitus, Diabetic Foot Ulcer, TMJ, Oral Health, Quality of Life
- Medical subject headings
- Diabetic Foot, Temporomandibular Joint Disorders, Deglutition Disorders, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
Planned measurements and scales will be applied
| Study group | Role | What they receive |
|---|---|---|
| Study Group | 42 patients with diabetic foot ulcers were included. For patients in this group, regarding diabetic foot; Sensory assessment, ulcer area and depth measurement, and diabetes management information were measured.
Apart from these evaluations, quality of life, pain, mandibular function and oropharyngeal swallowing problems were evaluated. Receives: Other: observation | |
| Control Group | 42 patients without diabetes were included. Patients in this group were evaluated for general health and quality of life, pain, mandibular function and oropharyngeal swallowing problems. Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporomandibular Dysfunction
An umbrella term covering pain and dysfunction of the muscles of mastication (the muscles that move the jaw) and the temporomandibular joints (the joints which connect the mandible to the skull). Temporomandibular Dysfunction was assessed using the Mandibular Function Disorder Questionnaire. This valid and reliable scale evaluating mandibular dysfunction consists of two dimensions and 17 questions. The first 11 items form the Functional Capacity dimension, and the next six items form the Nutrition dimension. Each question is scored from '0' (no difficulty) to '4' (very difficult or impossible without assistance). A high total score obtained from the questionnaire indicates a high level of impairment in jaw function.
Measured: baseline
Secondary outcomes (3)
Quality of life assessment
Quality of life is an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. The participants' quality of life was evaluated using the Ferrans\&Powers Quality of Life Index Diabetes Version.The Quality of Life Assessment Index consists of two parts and a total of 68 items. In the first part, in 6-point Likert order (1=not at all satisfied, 6=very satisfied) the patient's satisfaction/pleasure in various areas of life; In the second part (1=not at all important, 6=very important) the importance levels of various life areas of the patient are questioned. It is scored in the categories of health and functional capacity, socioeconomic status, psychological belief status, family status, and total quality of life. A high score indicates a good quality of life.
Measured: baseline
Swallowing Disorders
Swallowing disorders (Dysphagia) is the medical term for swallowing difficulties. Some people with dysphagia have problems swallowing certain foods or liquids, while others can't swallow at all. Participants' swallowing disorders were evaluated using the Eating Assessment Tool (EAT-10). The scale, which evaluates the symptoms and severity of oropharyngeal swallowing disorder and is valid and reliable, consists of 10 questions. Each question is scored between '0' (no problem) and '4' (serious problem). A total score of 3 and above on the scale between 0-40 indicates a swallowing problem.
Measured: baseline
Pain assessment
Participants' pain reports were evaluated using the Numerical Rating Scale (NRS). It is a simple, valid, and reliable method that is frequently used in measuring the severity of pain in the clinic. The participant is asked to mark a number on a 10 cm scale, on which numbers are shown in the range of "0" (no pain) to "10" (unbearable pain) for the pain he feels in the TMJ region
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start5 Jan 2023
- Primary completion5 Jun 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Enzin, Harran University
- Investigators
- Fatih Enzin, asst prof dr, Principal investigator, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067022
- Sponsor's protocol ID
- fatihenzin
- Status last verified
- Sep 2023
- First submitted
- 19 Sep 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporomandibular Dysfunction in Patients With Diabetic Foot Ulcers: What Could Be the Predictors?
- ClinicalTrials.gov ID
- NCT06067022
- Acronym / sponsor ID
- fatihenzin
- Keywords
- Diabetes Mellitus, Diabetic Foot Ulcer, TMJ, Oral Health, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 4 Oct 2023 (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.
The aim of this observational study is to investigate the effects of the type, area and duration of ulceration on jaw pain, mandibular function limitation, TMD and swallowing in individuals with diabetic foot ulcers.The main questions it aims to answer are:
- Does the change in foot structure due to diabetic foot ulcer have an effect on the temporomandibular jointand swalloving?
- What are the determinants of tempomandibular dysfunction in individuals with diabetic foot ulcers?
Participants (both groups) will be evaluated for quality of life, jaw functionality, mandibular dysfunction, oropharyngeal swallowing disorder, pain and diabetes complications.
Detailed description
The study was planned in an observational case-control study design. 84 participants were included. Individuals who signed the Informed Consent Form were included in the study. Individuals aged between 46-80 (min-max) who were diagnosed with type 2 DM and DFU in Harran University Research and Application Hospital Endocrinology Polyclinic were included in the study group, and healthy individuals aged 37-85 (min-max) without a diagnosis of DM were included in the control group. Among the exclusion criteria for all individuals from the study, the Mini-Mental Test score should be below 24, history of psychiatric illness, cancer, neurological problems, congenital anomalies, musculoskeletal problems, having a systemic disease, facial paralysis, undergoing surgery due to spine, abdomen and/or TMJ problem and receiving any treatment related to the spine and TMJ in less than 6 months.
In the clinical evaluation of individuals with DFU about diabetes and ulcers; diabetes duration, HbA1C value, glycemic control adequacy, and peripheral arterial disease were recorded, monofilament test was performed for sensory evaluation. Ulcer type and duration were recorded, and ulcer area was measured. Individuals' quality of life was evaluated with the Ferran Powers Quality of Life Index. In the evaluation of oral health in all participants; burning mouth syndrome, dry mouth sensation, tooth loss, tooth decay, and intraoral lesions were questioned.
Participants' pain reports were evaluated using the Numerical Rating Scale (NRS).
Participants' swallowing disorders were evaluated using the Eating Assessment Tool (EAT-10).
Participants' TMJ disorders were evaluated using the Fonseca Anamnestic Index.
Participants' mandibular dysfunctions were evaluated using the Mandibular Function Disorder Questionnaire .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: observation42 patients with diabetic foot ulcers were included. For patients in this group, regarding diabetic foot; Sensory assessment, ulcer area and depth measurement, and diabetes management information were measured. Apart from these evaluations, quality of life, pain, mandibular function and oropharyngeal swallowing problems were evaluated. |
| Control Group | – | Other: observation42 patients without diabetes were included. Patients in this group were evaluated for general health and quality of life, pain, mandibular function and oropharyngeal swallowing problems. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- Being over 18 years old
- Having been diagnosed with Type 2 diabetes for at least 10 years
- Not having a serious musculoskeletal, cardiac, neurological, etc. systemic disorder that may interfere with the research.
- Not having any communication problems
Key exclusion criteria (10 listed)
- Having a diabetic foot ulcer
- Having a diagnosed psychiatric disease,
- Having had a temporomandibular joint operation,
- Having experienced direct or indirect trauma to the head-neck and spine area,
- Having had previous spine surgery,
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 |
|---|---|---|
| observationPlanned measurements and scales will be applied | Other | Control Group, Study Group |
Primary outcome
Temporomandibular Dysfunction
Time frame: baseline
An umbrella term covering pain and dysfunction of the muscles of mastication (the muscles that move the jaw) and the temporomandibular joints (the joints which connect the mandible to the skull). Temporomandibular Dysfunction was assessed using the Mandibular Function Disorder Questionnaire. This valid and reliable scale evaluating mandibular dysfunction consists of two dimensions and 17 questions. The first 11 items form the Functional Capacity dimension, and the next six items form the Nutrition dimension. Each question is scored from '0' (no difficulty) to '4' (very difficult or impossible without assistance). A high total score obtained from the questionnaire indicates a high level of impairment in jaw function.
3 secondary outcomes
Quality of life assessment
Time frame: baseline
Swallowing Disorders
Time frame: baseline
Pain assessment
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Fatih Enzin, asst prof dr principal investigator
Harran University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer and Temporomandibular Disorder, run by Harran University at 1 site in Turkey (Türkiye).
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 10 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 4 Oct 2023. 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 Turkey (Türkiye). 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?
Temporomandibular Dysfunction (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2023.