Plantar FascitisNCT04894383
Plantar Fasciitis and the Use of Orthotics as Treatment
A study testing Aetrex L420 Compete Orthotic and Aetrex indoor comfort sandal with built-in arch support in people with Plantar Fascitis, run by Talita Cumi Ltd. at 1 site in United Kingdom.
Trial summary
To investigate whether the use of prefabricated Orthotics in shoes, in combination with the use of indoor comfort sandals with built-in arch support, benefits the treatment of plantar fasciitis more than the sole use of prefabricated Orthotics in shoes alone. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Aetrex L420 Compete Orthotic and Aetrex indoor comfort sandal with built-in arch support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jul 2021to 31 Jan 2023
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have been experiencing symptoms of Plantar Fasciitis for at least 2 months. A diagnosis of plantar fasciitis will be made on the criteria that the pain is located on the medial aspect of the heel on palpation and the pain is worst the first thing in the morning.
- Aged 19-75 years old
Who cannot join
- Prior operations on the foot,
- Prior treatments apart from analgesia in the last 12 months e.g. corticosteroid injections,
- Congenital or acquired foot and ankle abnormalities which prevent the use of normal footwear.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Into the Use of Prefabricated Orthotics in Shoes, in Combination With Using Indoor Comfort Sandals With built-in Arch Support vs. the Sole Use of Prefabricated Orthotics in Shoes Alone, for the Treatment of Plantar Fasciitis. A Randomised Control Trial
To investigate whether the use of prefabricated Orthotics in shoes, in combination with the use of indoor comfort sandals with built-in arch support, benefits the treatment of plantar fasciitis more than the sole use of prefabricated Orthotics in shoes alone.
Read the detailed description
The usual symptom of plantar fasciitis is "first-step pain", though plantar heel pain in general can be broadly associated with plantar fasciitis. Although most of the cases resolve within 10 months, 10% develop chronic plantar fasciitis. The pathomechanics of the condition is assumed to be due to excessive tensile loading, exacerbated by abnormal biomechanics of the legs such as pes planus, leg length discrepancy, and tightness of calf muscles.
Foot Orthotics are commonly used in the conservative treatment of plantar fasciitis. It is thought that foot Orthotics reduce the symptoms of plantar fasciitis by reducing strain in the fascia during standing and ambulation. A handful of randomized controlled trials have evaluated the effects of foot Orthotics from a patient's perspective. However, systematic reviews of these trials have concluded that the evidence for the effectiveness of foot Orthotics in the treatment of plantar fasciitis is poor and that further investigation is needed. In addition, the limitation of the success of using orthotics may be because Orthotics can only be used in conjunction with shoes. Many people may not wear shoes when at home, meaning the Orthotics are not being used during this time. The feet are therefore unsupported for a significant number of hours when weight-bearing (walking and standing) without shoes. This research, therefore, involves testing the addition of contoured comfort sandals with built-in arch support that can be worn while at home, as well as the Orthotics which will be worn during the day with shoes. Contemporaneous research on Orthotics is limited to only using Orthotics and there are no studies that use both the Orthotics and comfort sandal.
This is a randomised control trial that will be conducted over a 6-month period, during which participants will be asked to provide data in the form of completed surveys at 5 points throughout the study period. The aim of the study is to investigate whether the use of prefabricated Orthotics in shoes, in combination with the use of indoor comfort sandals with built-in arch support, benefits the treatment of plantar fasciitis more than the sole use of prefabricated Orthotics in shoes alone.
The study population will include 104 participants who will be randomised into a study and control group. Participants in the study group will be asked to insert the Orthotics into normal footwear and to use them wherever possible. Participants will also be instructed to use the comfort sandal with built-in arch support when not using shoes whilst at home. Participants in group B will only be asked to use the Orthotic inserted into daily footwear wherever suitable (i.e. when outside of the home). Participants from both groups will be asked to continue with normal activities throughout the study period.
During the 6 month study period, all participants will be asked to complete and submit surveys at baseline, 3 weeks, 6 weeks, 3 months and 6 months from entry into the study.
- Conditions
- Plantar Fascitis
- Being tested
- Aetrex L420 Compete Orthotic, Aetrex indoor comfort sandal with built-in arch support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aetrex L420 Compete OrthoticDevice
An orthotic insole to be inserted into shoes. Orthotic for low arches to flat feet with no forefoot pain, featuring a posted heel to control over-pronation and provide balance. Features Aetrex Arch Support to help biomechanically align the body \& help prevent common foot pain such as Plantar Fasciitis, Arch Pain and Metatarsalgia.
Aetrex indoor comfort sandal with built-in arch supportDevice
An indoor comfort sandal with built-in arch support to be used at home. Provides extreme cushioning, shock absorption and durability. Arch support helps to stabilize and align feet and also helps to relieve common foot pain \& plantar fasciitis.
| Study group | Role | What they receive |
|---|---|---|
| Prefabricated Orthotics in shoes & indoor comfort sandals with built-in arch support | Experimental | Participants from Group A will receive an L400 Compete Orthotic (https://www.aetrex.com/search?q=l420\&search-button=\&lang=en_US) and an Aetrex comfort sandal with built-in arch support (https://www.aetrex.com/aetrex-flips-black-L3000M.html?lang=en_US or https://www.aetrex.com/fiji-flips-women-watermelon-L7009W.html?lang=en_US) according to participants shoe size. The investigators will send an instruction sheet along with the Orthotic in the post, explaining how to use it. Alternatively, an online video tutorial on how to use the Orthotic will also be available throughout the study. The group will be asked to continue with usual activities, using the orthotic/comfort sandal wherever possible. Receives: Device: Aetrex L420 Compete Orthotic; Device: Aetrex indoor comfort sandal with built-in arch support |
| Prefabricated Orthotics in shoes only | Active comparator | Group B will receive an L400 Compete Orthotic (https://www.aetrex.com/search?q=l420\&search-button=\&lang=en_US) alone. The investigators will send an instruction sheet along with the Orthotic in the post, explaining how to use it. Alternatively, an online video tutorial on how to use the Orthotic will also be available throughout the study. The group will be asked to continue with usual activities, using the Orthotic wherever possible. Receives: Device: Aetrex L420 Compete Orthotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain as assessed by a Visual Analogue Scale (VAS)
Pain will be collected on via a self-report Visual Analogue Scale (VAS) as follows: 0 to 10 where 0 is 'No Pain' and 10 is 'The worst imaginable pain'.
Measured: Baseline, 3 weeks, 6 weeks, 3 months and 6 months
Secondary outcomes (2)
Changes in Foot health status as assessed by the Foot Health Status Questionnaire (FHSQ)
Foot Pain \& Functionality scores will be collected using the FHSQ or Foot Health Status Questionnaire. The Foot Health Status Questionnaire is designed to assess foot pain, foot health and its relation to quality of life. The questionnaire has four domains consisting of 13 key items. The four domains are; foot pain, foot function, footwear and general foot health. The current study will only use the 2 subsections of Foot Pain and Foot Function. In these subsections, participants will be required to rate foot pain in the last week from 1 (none) to 5 (severe), how often the participant experienced different types of foot pain during the last week from 1 (never) to 5 (always), how much the participants feet interfered with everyday activities in the last week from 1 (not at all) to 5 (extremely) and overall foot health from 1 (excellent) to 5 (poor). Previous research has found the FHSQ to exhibit a strong degree of context, criterion and construct validity with high retest reliability.
Measured: Baseline, 3 weeks, 6 weeks, 3 months and 6 months
Changes in overall health as assessed by The Global Rating Scale of Change (GROC scale)
The Global Rating Scale of Change, or the GROC scale, will be used in the current study to assess participants overall health. This will give further insight into the effectiveness of the interventions. It is an 11 point scale from -5 to + 5. "-5" denotes "very much worse", "0" denotes "unchanged" and "+5" denotes "completely recovered".
Measured: Baseline, 3 weeks, 6 weeks, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start23 Jul 2021
- Primary completion11 Nov 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Plantar FascitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talita Cumi Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aetrex Worldwide Inc
- Responsible party
- Sponsor
- Investigators
- George Ampat, MBBS, MS, FRCS, Principal investigator, Talita Cumi Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894383
- Sponsor's protocol ID
- FFPETFETS002
- Status last verified
- May 2023
- First submitted
- 14 May 2021
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the study, data will be fully anonymised. Only non-identifiable, anonymised data will be archived along with the publication for use of other researchers. For instance, the age, sex, and study results of participants will be archived indefinitely as a supplementary document to the publication
Publications
Roos E, Engstrom M, Soderberg B. Foot orthoses for the treatment of plantar fasciitis. Foot Ankle Int. 2006 Aug;27(8):606-11. doi: 10.1177/107110070602700807.
PubMed 16919213Buchbinder R. Clinical practice. Plantar fasciitis. N Engl J Med. 2004 May 20;350(21):2159-66. doi: 10.1056/NEJMcp032745. No abstract available.
PubMed 15152061Wearing SC, Smeathers JE, Urry SR, Hennig EM, Hills AP. The pathomechanics of plantar fasciitis. Sports Med. 2006;36(7):585-611. doi: 10.2165/00007256-200636070-00004.
PubMed 16796396Bennett PJ, Patterson C. The foot health status questionnaire (FHSQ): a new instrument for measuring outcomes of foot care. Australasian J Podiatr Med. 1998;32:55-9.
Bennett PJ, Patterson C, Dunne MP. Health-related quality of life following podiatric surgery. J Am Podiatr Med Assoc. 2001 Apr;91(4):164-73. doi: 10.7547/87507315-91-4-164.
PubMed 11319246Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.
PubMed 20046623Riddle DL, Schappert SM. Volume of ambulatory care visits and patterns of care for patients diagnosed with plantar fasciitis: a national study of medical doctors. Foot Ankle Int. 2004 May;25(5):303-10. doi: 10.1177/107110070402500505.
PubMed 15134610Clement DB, Taunton JE, Smart GW, McNicol KL. A Survey of Overuse Running Injuries. Phys Sportsmed. 1981 May;9(5):47-58. doi: 10.1080/00913847.1981.11711077.
PubMed 27453020Davis PF, Severud E, Baxter DE. Painful heel syndrome: results of nonoperative treatment. Foot Ankle Int. 1994 Oct;15(10):531-5. doi: 10.1177/107110079401501002.
PubMed 7834059Kogler GF, Solomonidis SE, Paul JP. Biomechanics of longitudinal arch support mechanisms in foot orthoses and their effect on plantar aponeurosis strain. Clin Biomech (Bristol). 1996 Jul;11(5):243-252. doi: 10.1016/0268-0033(96)00019-8.
PubMed 11415628Kitaoka HB, Luo ZP, An KN. Analysis of longitudinal arch supports in stabilizing the arch of the foot. Clin Orthop Relat Res. 1997 Aug;(341):250-6.
PubMed 9269181Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82.
PubMed 21916393Crawford F, Atkins D, Young P, Edwards J. Steroid injection for heel pain: evidence of short-term effectiveness. A randomized controlled trial. Rheumatology (Oxford). 1999 Oct;38(10):974-7. doi: 10.1093/rheumatology/38.10.974.
PubMed 10534548Acevedo JI, Beskin JL. Complications of plantar fascia rupture associated with corticosteroid injection. Foot Ankle Int. 1998 Feb;19(2):91-7. doi: 10.1177/107110079801900207.
PubMed 9498581Leach R, Jones R, Silva T. Rupture of the plantar fascia in athletes. J Bone Joint Surg Am. 1978 Jun;60(4):537-9.
PubMed 27524
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Into the Use of Prefabricated Orthotics in Shoes, in Combination With Using Indoor Comfort Sandals With built-in Arch Support vs. the Sole Use of Prefabricated Orthotics in Shoes Alone, for the Treatment of Plantar Fasciitis. A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT04894383
- Acronym / sponsor ID
- FFPETFETS002
- Conditions
- Plantar Fascitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Talita Cumi Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Aetrex Worldwide Inc
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 20 May 2021 (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.
To investigate whether the use of prefabricated Orthotics in shoes, in combination with the use of indoor comfort sandals with built-in arch support, benefits the treatment of plantar fasciitis more than the sole use of prefabricated Orthotics in shoes alone.
Detailed description
The usual symptom of plantar fasciitis is "first-step pain", though plantar heel pain in general can be broadly associated with plantar fasciitis. Although most of the cases resolve within 10 months, 10% develop chronic plantar fasciitis. The pathomechanics of the condition is assumed to be due to excessive tensile loading, exacerbated by abnormal biomechanics of the legs such as pes planus, leg length discrepancy, and tightness of calf muscles.
Foot Orthotics are commonly used in the conservative treatment of plantar fasciitis. It is thought that foot Orthotics reduce the symptoms of plantar fasciitis by reducing strain in the fascia during standing and ambulation. A handful of randomized controlled trials have evaluated the effects of foot Orthotics from a patient's perspective. However, systematic reviews of these trials have concluded that the evidence for the effectiveness of foot Orthotics in the treatment of plantar fasciitis is poor and that further investigation is needed. In addition, the limitation of the success of using orthotics may be because Orthotics can only be used in conjunction with shoes. Many people may not wear shoes when at home, meaning the Orthotics are not being used during this time. The feet are therefore unsupported for a significant number of hours when weight-bearing (walking and standing) without shoes. This research, therefore, involves testing the addition of contoured comfort sandals with built-in arch support that can be worn while at home, as well as the Orthotics which will be worn during the day with shoes. Contemporaneous research on Orthotics is limited to only using Orthotics and there are no studies that use both the Orthotics and comfort sandal.
This is a randomised control trial that will be conducted over a 6-month period, during which participants will be asked to provide data in the form of completed surveys at 5 points throughout the study period. The aim of the study is to investigate whether the use of prefabricated Orthotics in shoes, in combination with the use of indoor comfort sandals with built-in arch support, benefits the treatment of plantar fasciitis more than the sole use of prefabricated Orthotics in shoes alone.
The study population will include 104 participants who will be randomised into a study and control group. Participants in the study group will be asked to insert the Orthotics into normal footwear and to use them wherever possible. Participants will also be instructed to use the comfort sandal with built-in arch support when not using shoes whilst at home. Participants in group B will only be asked to use the Orthotic inserted into daily footwear wherever suitable (i.e. when outside of the home). Participants from both groups will be asked to continue with normal activities throughout the study period.
During the 6 month study period, all participants will be asked to complete and submit surveys at baseline, 3 weeks, 6 weeks, 3 months and 6 months from entry into the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prefabricated Orthotics in shoes & indoor comfort sandals with built-in arch support | Experimental | Device: Aetrex L420 Compete Orthotic, Device: Aetrex indoor comfort sandal with built-in arch supportParticipants from Group A will receive an L400 Compete Orthotic (https://www.aetrex.com/search?q=l420\&search-button=\&lang=en_US) and an Aetrex comfort sandal with built-in arch support (https://www.aetrex.com/aetrex-flips-black-L3000M.html?lang=en_US or https://www.aetrex.com/fiji-flips-women-watermelon-L7009W.html?lang=en_US) according to participants shoe size. The investigators will send an instruction sheet along with the Orthotic in the post, explaining how to use it. Alternatively, an online video tutorial on how to use the Orthotic will also be available throughout the study. The group will be asked to continue with usual activities, using the orthotic/comfort sandal wherever possible. |
| Prefabricated Orthotics in shoes only | Active comparator | Device: Aetrex L420 Compete OrthoticGroup B will receive an L400 Compete Orthotic (https://www.aetrex.com/search?q=l420\&search-button=\&lang=en_US) alone. The investigators will send an instruction sheet along with the Orthotic in the post, explaining how to use it. Alternatively, an online video tutorial on how to use the Orthotic will also be available throughout the study. The group will be asked to continue with usual activities, using the Orthotic wherever possible. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have been experiencing symptoms of Plantar Fasciitis for at least 2 months. A diagnosis of plantar fasciitis will be made on the criteria that the pain is located on the medial aspect of the heel on palpation and the pain is worst the first thing in the morning.
- Aged 19-75 years old
Key exclusion criteria (3 listed)
- Prior operations on the foot,
- Prior treatments apart from analgesia in the last 12 months e.g. corticosteroid injections,
- Congenital or acquired foot and ankle abnormalities which prevent the use of normal footwear.
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 |
|---|---|---|
| Aetrex L420 Compete OrthoticAn orthotic insole to be inserted into shoes. Orthotic for low arches to flat feet with no forefoot pain, featuring a posted heel to control over-pronation and provide balance. Features Aetrex Arch Support to help biomechanically align the body \& help prevent common foot pain such as Plantar Fasciitis, Arch Pain and Metatarsalgia. | Device | Prefabricated Orthotics in shoes & indoor comfort sandals with built-in arch support, Prefabricated Orthotics in shoes only |
| Aetrex indoor comfort sandal with built-in arch supportAn indoor comfort sandal with built-in arch support to be used at home. Provides extreme cushioning, shock absorption and durability. Arch support helps to stabilize and align feet and also helps to relieve common foot pain \& plantar fasciitis. | Device | Prefabricated Orthotics in shoes & indoor comfort sandals with built-in arch support |
Primary outcome
Changes in Pain as assessed by a Visual Analogue Scale (VAS)
Time frame: Baseline, 3 weeks, 6 weeks, 3 months and 6 months
Pain will be collected on via a self-report Visual Analogue Scale (VAS) as follows: 0 to 10 where 0 is 'No Pain' and 10 is 'The worst imaginable pain'.
2 secondary outcomes
Changes in Foot health status as assessed by the Foot Health Status Questionnaire (FHSQ)
Time frame: Baseline, 3 weeks, 6 weeks, 3 months and 6 months
Changes in overall health as assessed by The Global Rating Scale of Change (GROC scale)
Time frame: Baseline, 3 weeks, 6 weeks, 3 months and 6 months
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 6 May 2023.
- Background: PubMed 16919213Roos E, Engstrom M, Soderberg B. Foot orthoses for the treatment of plantar fasciitis. Foot Ankle Int. 2006 Aug;27(8):606-11. doi: 10.1177/107110070602700807.
- Background: PubMed 15152061Buchbinder R. Clinical practice. Plantar fasciitis. N Engl J Med. 2004 May 20;350(21):2159-66. doi: 10.1056/NEJMcp032745. No abstract available.
- Background: PubMed 16796396Wearing SC, Smeathers JE, Urry SR, Hennig EM, Hills AP. The pathomechanics of plantar fasciitis. Sports Med. 2006;36(7):585-611. doi: 10.2165/00007256-200636070-00004.
- BackgroundBennett PJ, Patterson C. The foot health status questionnaire (FHSQ): a new instrument for measuring outcomes of foot care. Australasian J Podiatr Med. 1998;32:55-9.
- Background: PubMed 11319246Bennett PJ, Patterson C, Dunne MP. Health-related quality of life following podiatric surgery. J Am Podiatr Med Assoc. 2001 Apr;91(4):164-73. doi: 10.7547/87507315-91-4-164.
- Background: PubMed 20046623Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.
- Results publication: PubMed 15134610Riddle DL, Schappert SM. Volume of ambulatory care visits and patterns of care for patients diagnosed with plantar fasciitis: a national study of medical doctors. Foot Ankle Int. 2004 May;25(5):303-10. doi: 10.1177/107110070402500505.
- Results publication: PubMed 27453020Clement DB, Taunton JE, Smart GW, McNicol KL. A Survey of Overuse Running Injuries. Phys Sportsmed. 1981 May;9(5):47-58. doi: 10.1080/00913847.1981.11711077.
- Results publication: PubMed 7834059Davis PF, Severud E, Baxter DE. Painful heel syndrome: results of nonoperative treatment. Foot Ankle Int. 1994 Oct;15(10):531-5. doi: 10.1177/107110079401501002.
- Results publication: PubMed 11415628Kogler GF, Solomonidis SE, Paul JP. Biomechanics of longitudinal arch support mechanisms in foot orthoses and their effect on plantar aponeurosis strain. Clin Biomech (Bristol). 1996 Jul;11(5):243-252. doi: 10.1016/0268-0033(96)00019-8.
- Results publication: PubMed 9269181Kitaoka HB, Luo ZP, An KN. Analysis of longitudinal arch supports in stabilizing the arch of the foot. Clin Orthop Relat Res. 1997 Aug;(341):250-6.
- Results publication: PubMed 21916393Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82.
- Individual participant dataSharing planned: Yes. At the end of the study, data will be fully anonymised. Only non-identifiable, anonymised data will be archived along with the publication for use of other researchers. For instance, the age, sex, and study results of participants will be archived indefinitely as a supplementary document to the publication
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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.
George Ampat, MBBS, MS, FRCS principal investigator
Talita Cumi Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aetrex L420 Compete Orthotic and Aetrex indoor comfort sandal with built-in arch support in people with Plantar Fascitis, run by Talita Cumi Ltd. at 1 site in United Kingdom.
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 3 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 6 May 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 United Kingdom. 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?
Changes in Pain as assessed by a Visual Analogue Scale (VAS) (time frame: Baseline, 3 weeks, 6 weeks, 3 months and 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 NCT04894383, which also lists 26 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 6 May 2023.