Diabetes Mellitus (DM)NCT02616263
Metatarsal Phalangeal Joint Deformity Progression - R01
A study testing Foot exercise and Shoulder exercise in people with Diabetes Mellitus (DM), run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this research study is to determine the relationships between foot muscle, foot motion, and toe deformity. Results from this investigation will help the investigators to understand what contributes to foot deformities and the role of the foot muscles in the development of foot deformities. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes Mellitus (DM)
- What is being tested?
- Foot exercise and Shoulder exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 29 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes Mellitus (DM)
- Diabetic peripheral neuropathy
Who cannot join
- active plantar ulcers, unable to ambulate or complete required testing, anyone who have amputations of their lower extremity (>1 toe), weigh more than 400 lbs, pregnant, have metal implants or pace makers (incompatible with MRI), greater than 75 years old, Subjects with other causes of PN (lumbar radiculopathy, microvascular disease, alcoholic/HIV/chemotaxic neuropathy), on dialysis, with peripheral arterial disease (ABI<0.9 or >1.3), with fixed MTPJ deformity (excursion <30 degrees active/passive), acute shoulder pain or disability that would prevent participation in shoulder specific intervention (i.e. severe shoulder pain >6/10, rotator cuff tear, upper extremity surgery, thoracic outlet syndrome);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Muscle, Joint and Movement Deterioration Contributing to Neuropathic Forefoot Deformity
The purpose of this research study is to determine the relationships between foot muscle, foot motion, and toe deformity. Results from this investigation will help the investigators to understand what contributes to foot deformities and the role of the foot muscles in the development of foot deformities. This could potentially guide treatment options focusing on strengthening the foot muscles to prevent or reduce the risk of developing a foot deformity.
Read the detailed description
The long term goal of this research is to reduce the incidence of lower extremity amputation in people with diabetes mellitus and peripheral neuropathy. It is hypothesized that muscle, joint, and movement deterioration associated with diabetes and peripheral neuropathy contribute to metatarsophalangeal joint (MTPJ) hyperextension deformity. MTPJ deformity results in excessive plantar stress on the insensitive forefoot, leading to ulceration and amputation. However, the specific cause of MTPJ deformity is not clear. The overall goal of this proposal is to identify the causes of MTPJ deformity and examine the ability of a targeted foot specific intervention to de-couple diabetes related mechanisms from MTPJ deformity and progression, following participants for 3 years. The investigators hypothesize that the cause of MTPJ deformity is an interaction of the accumulation of advanced glycation end products, muscle deterioration, limited joint mobility and compensatory movement strategies.
The specific aims are to determine:
- relationships between advanced glycation end products, intrinsic foot muscle volume, limited ankle dorsiflexion joint mobility, MTPJ hyperextension movement pattern, and MTPJ alignment;
- estimate the effect of a foot specific intervention on the MTPJ extension alignment and
- determine progression of MTPJ deformity and the predictors of progression over three years.
The following will be collected on participants with diabetes mellitus and peripheral neuropathy and monitored over three years to understand the causes and progression of MTPJ deformity:
- Skin intrinsic florescence to measure advanced glycation end product accumulation which increases collagen cross-linking and is associated with peripheral neuropathy, limited joint mobility, and muscle deterioration.
- Magnetic resonance images to measure intrinsic foot muscle deterioration that precedes extrinsic foot muscle deterioration as a result of distal to proximal peripheral neuropathy. The muscle imbalance of weak intrinsic foot muscles, the only muscles able to flex the MTPJ, in the presence of relatively stronger extrinsic toe extensors, results in a force couple that hyperextends the MTPJ.
- Kinematic and computed tomography measurement of foot and ankle joint positions to examine mobility and movement patterns that contribute to repeated and extreme MTPJ hyperextension during daily activities.
The investigators believe advanced glycation end products lead to limited ankle joint dorsiflexion. As a result, there is increased reliance on the extensor digitorum longus to assist in dorsiflexing the stiff ankle joint during activities like sit to stand. This study will have profound implications for reducing risk for skin breakdown and amputation by helping to understand and treat the causes of acquired neuropathic foot deformities. A successful foot specific intervention that improves MTPJ alignment will provide a non-invasive option to halt or slow the cascade of events leading to major lower extremity amputation, while improving function and minimizing disability.
- Conditions
- Diabetes Mellitus (DM)
- Being tested
- Foot exercise, Shoulder exercise
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot exerciseOther
Shoulder exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Foot Intervention | Experimental | The intervention is a progressive, home based exercise program aimed to increase ankle and foot plantarflexion muscle strength, increase ankle dorsiflexion and toe flexion range of motion, and to retrain individuals to dorsiflex the ankle while keeping the toes in a neutral position. A trained physical therapist with experience working with older adults with diabetes and foot specific complications will monitor and progress the exercise program assuring participant safety and maximizing exercise benefit. Receives: Other: Foot exercise |
| Shoulder Intervention | Active comparator | Participants will be trained in a progressive home exercise program that includes passive stretching of end range shoulder flexion and external rotation and a tailored dose of active shoulder motion. Receives: Other: Shoulder exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Metatarsal Phalangeal Joint Angle (Degrees) in People With Diabetes From Baseline and at a 3-year Period
The angle between the 2nd metatarsal and the proximal phalanx will be measured at baseline and again at the 3-years
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startMar 2016
- Primary completion29 Jun 2021
- Study completion29 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus (DM)Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Hastings, PT, DPT, ATC, Washington University School of Medicine
- Investigators
- Mary K Hastings, PT,DPT,MSCI, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616263
- Sponsor's protocol ID
- DK107809
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2015
- Last updated
- 2 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Other researchers may contact us to get access to the data but we will not be placing the data in a repository
Publications
Harris-Hayes M, Schootman M, Schootman JC, Hastings MK. The Role of Physical Therapists in Fighting the Type 2 Diabetes Epidemic. J Orthop Sports Phys Ther. 2020 Jan;50(1):5-16. doi: 10.2519/jospt.2020.9154. Epub 2019 Nov 28.
PubMed 31775555Hastings MK, Commean PK, Chen L, Zellers JA, Sinacore DR, Baker JC. Qualitative study of musculoskeletal tissues and their radiographic correlates in diabetic neuropathic foot deformity. Foot (Edinb). 2021 Jun;47:101777. doi: 10.1016/j.foot.2021.101777. Epub 2021 May 3.
PubMed 33957525Holmes CJ, Hastings MK. The Application of Exercise Training for Diabetic Peripheral Neuropathy. J Clin Med. 2021 Oct 28;10(21):5042. doi: 10.3390/jcm10215042.
PubMed 34768562Zellers JA, Commean PK, Chen L, Mueller MJ, Hastings MK. A limited number of slices yields comparable results to all slices in foot intrinsic muscle deterioration ratio on computed tomography and magnetic resonance imaging. J Biomech. 2021 Dec 2;129:110750. doi: 10.1016/j.jbiomech.2021.110750. Epub 2021 Sep 13.
PubMed 34555631Zellers JA, Eekhoff JD, Walk RE, Hastings MK, Tang SY, Lake SP. Human Achilles tendon mechanical behavior is more strongly related to collagen disorganization than advanced glycation end-products content. Sci Rep. 2021 Dec 17;11(1):24147. doi: 10.1038/s41598-021-03574-4.
PubMed 34921194Zellers JA, Mueller MJ, Commean PK, Chen L, Jeong HJ, Hastings MK. Multi-System Factors Associated with Metatarsophalangeal Joint Deformity in Individuals with Type 2 Diabetes. J Clin Med. 2020 Apr 3;9(4):1012. doi: 10.3390/jcm9041012.
PubMed 32260124Hastings MK, Jeong HJ, Sorensen CJ, Zellers JA, Chen L, Bohnert KL, Snozek D, Mueller MJ. Relationships within and between lower and upper extremity dysfunction in people with diabetes. Foot (Edinb). 2020 Sep;44:101680. doi: 10.1016/j.foot.2020.101680. Epub 2020 Mar 30.
PubMed 32679515Jeong HJ, Mueller MJ, Zellers JA, Hastings MK. Midfoot and ankle motion during heel rise and gait are related in people with diabetes and peripheral neuropathy. Gait Posture. 2021 Feb;84:38-44. doi: 10.1016/j.gaitpost.2020.11.013. Epub 2020 Nov 16.
PubMed 33264731Jeong HJ, Mueller MJ, Zellers JA, Yan Y, Hastings MK. Heel Rise and Non-Weight-Bearing Ankle Plantar Flexion Tasks to Assess Foot and Ankle Function in People With Diabetes Mellitus and Peripheral Neuropathy. Phys Ther. 2021 Jul 1;101(7):pzab096. doi: 10.1093/ptj/pzab096.
PubMed 33735386Zellers JA, Bernhardson HJ, Jeong HJ, Commean PK, Chen L, Mueller MJ, Hastings MK. Association of toe-extension movement pattern magnitude and variability during three functional tasks with diabetic foot complications. Clin Biomech (Bristol). 2021 May;85:105371. doi: 10.1016/j.clinbiomech.2021.105371. Epub 2021 May 3.
PubMed 33965738Jeong HJ, Mueller MJ, Zellers JA, Commean PK, Chen L, Hastings MK. Body mass index and maximum available midfoot motion are associated with midfoot angle at peak heel rise in people with type 2 diabetes mellitus and peripheral neuropathy. Foot (Edinb). 2022 May;51:101912. doi: 10.1016/j.foot.2022.101912. Epub 2022 Feb 11.
PubMed 35255403Jeong HJ, Cha B, Zellers JA, Chen L, Hastings MK. Midfoot and ankle movement coordination during heel rise is disrupted in people with diabetes and peripheral neuropathy. Clin Biomech (Bristol). 2022 Jun;96:105662. doi: 10.1016/j.clinbiomech.2022.105662. Epub 2022 May 7.
PubMed 35569256Bohnert KL, Zellers JA, Jeong HJ, Chen L, York A, Hastings MK. Remote Research: Resources, Intervention Needs, and Methods in People with Diabetes and Peripheral Neuropathy. J Diabetes Sci Technol. 2023 Jan;17(1):52-58. doi: 10.1177/19322968221103610. Epub 2022 Jun 30.
PubMed 35770988Youmans NJ, Vaidya RS, Chen L, Jeong HJ, York A, Commean PK, Hastings MK, Zellers JA. Rate of tarsal and metatarsal bone mineral density change in adults with diabetes mellitus and peripheral neuropathy: a longitudinal study. J Foot Ankle Res. 2023 Feb 13;16(1):6. doi: 10.1186/s13047-023-00606-2.
PubMed 36782282
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle, Joint and Movement Deterioration Contributing to Neuropathic Forefoot Deformity
- ClinicalTrials.gov ID
- NCT02616263
- Acronym / sponsor ID
- DK107809
- Conditions
- Diabetes Mellitus (DM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Posted 2 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine the relationships between foot muscle, foot motion, and toe deformity. Results from this investigation will help the investigators to understand what contributes to foot deformities and the role of the foot muscles in the development of foot deformities. This could potentially guide treatment options focusing on strengthening the foot muscles to prevent or reduce the risk of developing a foot deformity.
Detailed description
The long term goal of this research is to reduce the incidence of lower extremity amputation in people with diabetes mellitus and peripheral neuropathy. It is hypothesized that muscle, joint, and movement deterioration associated with diabetes and peripheral neuropathy contribute to metatarsophalangeal joint (MTPJ) hyperextension deformity. MTPJ deformity results in excessive plantar stress on the insensitive forefoot, leading to ulceration and amputation. However, the specific cause of MTPJ deformity is not clear. The overall goal of this proposal is to identify the causes of MTPJ deformity and examine the ability of a targeted foot specific intervention to de-couple diabetes related mechanisms from MTPJ deformity and progression, following participants for 3 years. The investigators hypothesize that the cause of MTPJ deformity is an interaction of the accumulation of advanced glycation end products, muscle deterioration, limited joint mobility and compensatory movement strategies.
The specific aims are to determine:
- relationships between advanced glycation end products, intrinsic foot muscle volume, limited ankle dorsiflexion joint mobility, MTPJ hyperextension movement pattern, and MTPJ alignment;
- estimate the effect of a foot specific intervention on the MTPJ extension alignment and
- determine progression of MTPJ deformity and the predictors of progression over three years.
The following will be collected on participants with diabetes mellitus and peripheral neuropathy and monitored over three years to understand the causes and progression of MTPJ deformity:
- Skin intrinsic florescence to measure advanced glycation end product accumulation which increases collagen cross-linking and is associated with peripheral neuropathy, limited joint mobility, and muscle deterioration.
- Magnetic resonance images to measure intrinsic foot muscle deterioration that precedes extrinsic foot muscle deterioration as a result of distal to proximal peripheral neuropathy. The muscle imbalance of weak intrinsic foot muscles, the only muscles able to flex the MTPJ, in the presence of relatively stronger extrinsic toe extensors, results in a force couple that hyperextends the MTPJ.
- Kinematic and computed tomography measurement of foot and ankle joint positions to examine mobility and movement patterns that contribute to repeated and extreme MTPJ hyperextension during daily activities.
The investigators believe advanced glycation end products lead to limited ankle joint dorsiflexion. As a result, there is increased reliance on the extensor digitorum longus to assist in dorsiflexing the stiff ankle joint during activities like sit to stand. This study will have profound implications for reducing risk for skin breakdown and amputation by helping to understand and treat the causes of acquired neuropathic foot deformities. A successful foot specific intervention that improves MTPJ alignment will provide a non-invasive option to halt or slow the cascade of events leading to major lower extremity amputation, while improving function and minimizing disability.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foot Intervention | Experimental | Other: Foot exerciseThe intervention is a progressive, home based exercise program aimed to increase ankle and foot plantarflexion muscle strength, increase ankle dorsiflexion and toe flexion range of motion, and to retrain individuals to dorsiflex the ankle while keeping the toes in a neutral position. A trained physical therapist with experience working with older adults with diabetes and foot specific complications will monitor and progress the exercise program assuring participant safety and maximizing exercise benefit. |
| Shoulder Intervention | Active comparator | Other: Shoulder exerciseParticipants will be trained in a progressive home exercise program that includes passive stretching of end range shoulder flexion and external rotation and a tailored dose of active shoulder motion. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 Diabetes Mellitus (DM)
- Diabetic peripheral neuropathy
Key exclusion criteria (1 listed)
- active plantar ulcers, unable to ambulate or complete required testing, anyone who have amputations of their lower extremity (>1 toe), weigh more than 400 lbs, pregnant, have metal implants or pace makers (incompatible with MRI), greater than 75 years old, Subjects with other causes of PN (lumbar radiculopathy, microvascular disease, alcoholic/HIV/chemotaxic neuropathy), on dialysis, with peripheral arterial disease (ABI<0.9 or >1.3), with fixed MTPJ deformity (excursion <30 degrees active/passive), acute shoulder pain or disability that would prevent participation in shoulder specific intervention (i.e. severe shoulder pain >6/10, rotator cuff tear, upper extremity surgery, thoracic outlet syndrome);
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 |
|---|---|---|
| Foot exercise | Other | Foot Intervention |
| Shoulder exercise | Other | Shoulder Intervention |
Primary outcome
Change in Metatarsal Phalangeal Joint Angle (Degrees) in People With Diabetes From Baseline and at a 3-year Period
Time frame: Three years
The angle between the 2nd metatarsal and the proximal phalanx will be measured at baseline and again at the 3-years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31775555Harris-Hayes M, Schootman M, Schootman JC, Hastings MK. The Role of Physical Therapists in Fighting the Type 2 Diabetes Epidemic. J Orthop Sports Phys Ther. 2020 Jan;50(1):5-16. doi: 10.2519/jospt.2020.9154. Epub 2019 Nov 28.
- Background: PubMed 33957525Hastings MK, Commean PK, Chen L, Zellers JA, Sinacore DR, Baker JC. Qualitative study of musculoskeletal tissues and their radiographic correlates in diabetic neuropathic foot deformity. Foot (Edinb). 2021 Jun;47:101777. doi: 10.1016/j.foot.2021.101777. Epub 2021 May 3.
- Background: PubMed 34768562Holmes CJ, Hastings MK. The Application of Exercise Training for Diabetic Peripheral Neuropathy. J Clin Med. 2021 Oct 28;10(21):5042. doi: 10.3390/jcm10215042.
- Background: PubMed 34555631Zellers JA, Commean PK, Chen L, Mueller MJ, Hastings MK. A limited number of slices yields comparable results to all slices in foot intrinsic muscle deterioration ratio on computed tomography and magnetic resonance imaging. J Biomech. 2021 Dec 2;129:110750. doi: 10.1016/j.jbiomech.2021.110750. Epub 2021 Sep 13.
- Background: PubMed 34921194Zellers JA, Eekhoff JD, Walk RE, Hastings MK, Tang SY, Lake SP. Human Achilles tendon mechanical behavior is more strongly related to collagen disorganization than advanced glycation end-products content. Sci Rep. 2021 Dec 17;11(1):24147. doi: 10.1038/s41598-021-03574-4.
- Results publication: PubMed 32260124Zellers JA, Mueller MJ, Commean PK, Chen L, Jeong HJ, Hastings MK. Multi-System Factors Associated with Metatarsophalangeal Joint Deformity in Individuals with Type 2 Diabetes. J Clin Med. 2020 Apr 3;9(4):1012. doi: 10.3390/jcm9041012.
- Results publication: PubMed 32679515Hastings MK, Jeong HJ, Sorensen CJ, Zellers JA, Chen L, Bohnert KL, Snozek D, Mueller MJ. Relationships within and between lower and upper extremity dysfunction in people with diabetes. Foot (Edinb). 2020 Sep;44:101680. doi: 10.1016/j.foot.2020.101680. Epub 2020 Mar 30.
- Results publication: PubMed 33264731Jeong HJ, Mueller MJ, Zellers JA, Hastings MK. Midfoot and ankle motion during heel rise and gait are related in people with diabetes and peripheral neuropathy. Gait Posture. 2021 Feb;84:38-44. doi: 10.1016/j.gaitpost.2020.11.013. Epub 2020 Nov 16.
- Results publication: PubMed 33735386Jeong HJ, Mueller MJ, Zellers JA, Yan Y, Hastings MK. Heel Rise and Non-Weight-Bearing Ankle Plantar Flexion Tasks to Assess Foot and Ankle Function in People With Diabetes Mellitus and Peripheral Neuropathy. Phys Ther. 2021 Jul 1;101(7):pzab096. doi: 10.1093/ptj/pzab096.
- Results publication: PubMed 33965738Zellers JA, Bernhardson HJ, Jeong HJ, Commean PK, Chen L, Mueller MJ, Hastings MK. Association of toe-extension movement pattern magnitude and variability during three functional tasks with diabetic foot complications. Clin Biomech (Bristol). 2021 May;85:105371. doi: 10.1016/j.clinbiomech.2021.105371. Epub 2021 May 3.
- Results publication: PubMed 35255403Jeong HJ, Mueller MJ, Zellers JA, Commean PK, Chen L, Hastings MK. Body mass index and maximum available midfoot motion are associated with midfoot angle at peak heel rise in people with type 2 diabetes mellitus and peripheral neuropathy. Foot (Edinb). 2022 May;51:101912. doi: 10.1016/j.foot.2022.101912. Epub 2022 Feb 11.
- Results publication: PubMed 35569256Jeong HJ, Cha B, Zellers JA, Chen L, Hastings MK. Midfoot and ankle movement coordination during heel rise is disrupted in people with diabetes and peripheral neuropathy. Clin Biomech (Bristol). 2022 Jun;96:105662. doi: 10.1016/j.clinbiomech.2022.105662. Epub 2022 May 7.
- Individual participant dataSharing planned: No. Other researchers may contact us to get access to the data but we will not be placing the data in a repository
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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.
Mary K Hastings, PT,DPT,MSCI principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot exercise and Shoulder exercise in people with Diabetes Mellitus (DM), run by Washington University School of Medicine at 1 site in United States.
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 2 inclusion and 1 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 2 Dec 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Metatarsal Phalangeal Joint Angle (Degrees) in People With Diabetes From Baseline and at a 3-year Period (time frame: Three years). 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 NCT02616263, which also lists 14 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 2 Dec 2024.