Plantar FasciitisNCT05584046
A Double-blind RCT to Investigate the Effect of a Novel Herbal Patch for the Treatment of PF
A study testing CDAM and 2% Ketoprofen Patch in people with Plantar Fasciitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Disorders and injuries of tendons and ligaments are some of the most diagnosed musculoskeletal (MS) disorders clinically. Nearly half of the 33 million MS disorders reported in the United States each year are tendon and ligament injuries. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- CDAM and 2% Ketoprofen Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Sep 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female with age 18-70
- Unilateral
- Heel pain for more than 6 weeks' duration
- VAS score ≥ 5
- Signed informed consent.
Who cannot join
- Known chronic disease or receiving long-term medications affecting bone metabolism including BPs
- Contraindication to alendronate therapy such as poor dental fitness
- ACL injury less than 6 weeks
- Injury on duty cases
- Patients who have undergone arthroscopy or open surgery in the index knee in the last 12 months
- Other associated injuries (fractures and other ligament involvement such as neurovascular bundles injury)
Show all 11Show fewer
- Chondral lesion with concomitant intervention
- Presence of X-ray features of osteoarthritis including decrease in joint space, presence of osteophytes and subchondral cysts
- Neurological deficit
- Pregnant or breastfeeding
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Pauline LUI, PhD, +852 3505 2730, paulinelui@cuhk.edu.hk
About this study
Official title: Effect of a Novel Herbal Patch for the Treatment of Plantar Fasciitis - A SingleDouble-blind Randomized Controlled Trial
Disorders and injuries of tendons and ligaments are some of the most diagnosed musculoskeletal (MS) disorders clinically. Nearly half of the 33 million MS disorders reported in the United States each year are tendon and ligament injuries. Although most of such injuries are non-fatal, they are severely debilitating, resulting in significant reduction in patient's quality of life, loss of productivity, and considerable costs to the healthcare system.
Among all tendon and ligament disorders and injuries, tendon and ligament overuse disorders are the most common and incapacitating ones. Tendinopathy is a painful tendon overuse disorder, which increases with population aging. It has been estimated that about 30% of consultations for MS complaints in a general practice were related to tendinopathy. The affected tendon is presented with local tenderness, swelling and pain, causing physical disability of the affected individual. The affected tendon degenerates and finally ruptures. Common sites of tendinopathy include supraspinatus, common wrist extensor, flexor tendon, patellar tendon, and Achilles tendon. The outcomes of both conservative treatments and surgeries are not satisfactory, with recurrent pain and tendon retear after surgery.
Read more
Plantar fasciitis is a chronic painful, degenerative condition of the plantar fascia. It is caused by repetitive traumas at its origin on the calcaneus. Plantar fascia is a thick, ribbon-like fibrous ligament that connects the medial calcaneal tubercle to the heads of the metatarsal bones. It contributes to the support of the foot arch by acting as a tie-rod, where it undergoes tension when the foot bears weight. Therefore, although plantar fascia is anatomically defined as a ligament, it functions similar to a tendon.
This study aims to conduct a randomized controlled study to test the efficacy of CDAM patch for the treatment of plantar fasciitis in patients.
- Conditions
- Plantar Fasciitis
- Being tested
- CDAM, 2% Ketoprofen Patch
- Keywords
- Plantar Fasciitis, Herbal Patch
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDAMOther
Novel drugs such as Traditional Chinese Medicine (TCM) formula that can suppress inflammation may augment tissue healing and reduce activity-related pain in patients suffering from plantar fasciitis. Our team has experiences of using TCM for the treatment of plantar fasciitis. Based on our previous experience, our group has developed a new proprietary topical TCM herbal formula, CDAM, containing Carthami Flos , Dipsaci Radix , Aconiti Lateralis Radix Praeparata and Herba Menthae for the treatment of plantar fasciitis.
2% Ketoprofen PatchOther
MOHRUS patch is the transdermal analgesic anti-inflammatory patch and is a standard treatment prescribed by doctor. Each patch contains 2% Ketoprofen and it is for the relief of pain and inflammation.
| Study group | Role | What they receive |
|---|---|---|
| CDAM group | Experimental | Patients receive the CDAM patch and a standard home stretching exercise program Receives: Other: CDAM |
| Active Control Group | Active comparator | Patients receive 2% Ketoprofen patch and a standard home stretching exercise program Receives: Other: 2% Ketoprofen Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Function Index (FFI) questionnaire
The FFI consists of 23 self-reported items divided into three subscales: limitation, pain and disability. The items are scored on a 10-point Likert scale. For each subscale, the raw score is transformed to a 100-point score, with higher score indicating worse limitation / pain / disability. The total score of FFI is the mean of the subscale scores. The Taiwan Chinese version of FFI has been validated.
Measured: Change from baseline FFI at 3 weeks
Foot Function Index (FFI) questionnaire
The FFI consists of 23 self-reported items divided into three subscales: limitation, pain and disability. The items are scored on a 10-point Likert scale. For each subscale, the raw score is transformed to a 100-point score, with higher score indicating worse limitation / pain / disability. The total score of FFI is the mean of the subscale scores. The Taiwan Chinese version of FFI has been validated.
Measured: Change from baseline FFI at 6 weeks
Foot Function Index (FFI) questionnaire
The FFI consists of 23 self-reported items divided into three subscales: limitation, pain and disability. The items are scored on a 10-point Likert scale. For each subscale, the raw score is transformed to a 100-point score, with higher score indicating worse limitation / pain / disability. The total score of FFI is the mean of the subscale scores. The Taiwan Chinese version of FFI has been validated.
Measured: Change from baseline FFI at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start20 Sep 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pauline Lui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584046
- Sponsor's protocol ID
- 2022.426
- Status last verified
- Aug 2026
- First submitted
- 14 Oct 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Novel Herbal Patch for the Treatment of Plantar Fasciitis - A SingleDouble-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05584046
- Acronym / sponsor ID
- 2022.426
- Conditions
- Plantar Fasciitis
- Keywords
- Plantar Fasciitis, Herbal Patch
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Oct 2022 (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.
Disorders and injuries of tendons and ligaments are some of the most diagnosed musculoskeletal (MS) disorders clinically. Nearly half of the 33 million MS disorders reported in the United States each year are tendon and ligament injuries. Although most of such injuries are non-fatal, they are severely debilitating, resulting in significant reduction in patient's quality of life, loss of productivity, and considerable costs to the healthcare system.
Among all tendon and ligament disorders and injuries, tendon and ligament overuse disorders are the most common and incapacitating ones. Tendinopathy is a painful tendon overuse disorder, which increases with population aging. It has been estimated that about 30% of consultations for MS complaints in a general practice were related to tendinopathy. The affected tendon is presented with local tenderness, swelling and pain, causing physical disability of the affected individual. The affected tendon degenerates and finally ruptures. Common sites of tendinopathy include supraspinatus, common wrist extensor, flexor tendon, patellar tendon, and Achilles tendon. The outcomes of both conservative treatments and surgeries are not satisfactory, with recurrent pain and tendon retear after surgery.
Plantar fasciitis is a chronic painful, degenerative condition of the plantar fascia. It is caused by repetitive traumas at its origin on the calcaneus. Plantar fascia is a thick, ribbon-like fibrous ligament that connects the medial calcaneal tubercle to the heads of the metatarsal bones. It contributes to the support of the foot arch by acting as a tie-rod, where it undergoes tension when the foot bears weight. Therefore, although plantar fascia is anatomically defined as a ligament, it functions similar to a tendon.
This study aims to conduct a randomized controlled study to test the efficacy of CDAM patch for the treatment of plantar fasciitis in patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDAM group | Experimental | Other: CDAMPatients receive the CDAM patch and a standard home stretching exercise program |
| Active Control Group | Active comparator | Other: 2% Ketoprofen PatchPatients receive 2% Ketoprofen patch and a standard home stretching exercise program |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female with age 18-70
- Unilateral
- Heel pain for more than 6 weeks' duration
- VAS score ≥ 5
- Signed informed consent.
Key exclusion criteria (11 listed)
- Known chronic disease or receiving long-term medications affecting bone metabolism including BPs
- Contraindication to alendronate therapy such as poor dental fitness
- ACL injury less than 6 weeks
- Injury on duty cases
- Patients who have undergone arthroscopy or open surgery in the index knee in the last 12 months
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 |
|---|---|---|
| CDAMNovel drugs such as Traditional Chinese Medicine (TCM) formula that can suppress inflammation may augment tissue healing and reduce activity-related pain in patients suffering from plantar fasciitis. Our team has experiences of using TCM for the treatment of plantar fasciitis. Based on our previous experience, our group has developed a new proprietary topical TCM herbal formula, CDAM, containing Carthami Flos , Dipsaci Radix , Aconiti Lateralis Radix Praeparata and Herba Menthae for the treatment of plantar fasciitis. | Other | CDAM group |
| 2% Ketoprofen PatchMOHRUS patch is the transdermal analgesic anti-inflammatory patch and is a standard treatment prescribed by doctor. Each patch contains 2% Ketoprofen and it is for the relief of pain and inflammation. | Other | Active Control Group |
Primary outcome
Foot Function Index (FFI) questionnaire
Time frame: Change from baseline FFI at 3 weeks
The FFI consists of 23 self-reported items divided into three subscales: limitation, pain and disability. The items are scored on a 10-point Likert scale. For each subscale, the raw score is transformed to a 100-point score, with higher score indicating worse limitation / pain / disability. The total score of FFI is the mean of the subscale scores. The Taiwan Chinese version of FFI has been validated.
Foot Function Index (FFI) questionnaire
Time frame: Change from baseline FFI at 6 weeks
The FFI consists of 23 self-reported items divided into three subscales: limitation, pain and disability. The items are scored on a 10-point Likert scale. For each subscale, the raw score is transformed to a 100-point score, with higher score indicating worse limitation / pain / disability. The total score of FFI is the mean of the subscale scores. The Taiwan Chinese version of FFI has been validated.
Foot Function Index (FFI) questionnaire
Time frame: Change from baseline FFI at 8 weeks
The FFI consists of 23 self-reported items divided into three subscales: limitation, pain and disability. The items are scored on a 10-point Likert scale. For each subscale, the raw score is transformed to a 100-point score, with higher score indicating worse limitation / pain / disability. The total score of FFI is the mean of the subscale scores. The Taiwan Chinese version of FFI has been validated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDAM and 2% Ketoprofen Patch in people with Plantar Fasciitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Shu-hang YUNG (+852 3505 2728, patrickyung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Function Index (FFI) questionnaire (time frame: Change from baseline FFI at 3 weeks). The study lists 3 primary outcomes in all. 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 12 Aug 2026.