PainEarly Phase 1NCT04655417
is Ultrasound-guided Foam Sclerotherapy a Cost-effective Alternate for Treatment of Varicose Veins?
A Early Phase 1 study testing Sodium Tetradecyl Sulfate in people with Pain and Leg Edema, run by Combined Military Hospital, Pakistan at 1 site in Pakistan.
Trial summary
. It is the aim of this paper is to discuss our experience of foam sclerotherapy for varicose veins atour hospital Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Leg Edema, Cost Effectiveness
- What is being tested?
- Sodium Tetradecyl Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Feb 2020to 21 Feb 2021
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All the patients who present with symptomatic varicose veins underwent a duplex scan by radiologist to identify site of reflux and condition of deep veins. If the patient is a candidate for intervention then he is offered surgery or foam sclerotherapy
Who cannot join
- recurrent and secondary varicose veins
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Anum Arif
Lahore, Select A State Or Province, 0092
Anum Arif, MBBS FCPS, 03422398424, dranumarif@yahoo.com
Ammad Asim, BCS MBA, 03333052892, AMMADASIM@GMAIL.COM
About this study
. It is the aim of this paper is to discuss our experience of foam sclerotherapy for varicose veins atour hospital
Read the detailed description
we will manage all patients with vericose veins with injection sclerotherapy and will monitor there response in terms of relive in vsisble veins, swelling and pain.
we also want to evaluate hoe many sessions of injection sclerotherapy are required for complete resolution of symptoms.
- Conditions
- Pain, Leg Edema, Cost Effectiveness, Cosmesis
- Being tested
- Sodium Tetradecyl Sulfate
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Tetradecyl SulfateDrug
Also called STS
DRUG WILL BE INJECTED TO ALLAPTIENTS ACCORDING TO STANDARD PROTOCOL
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION GROUP | Experimental | SINGLE ARM OF PATIENTS WHO WILL RECEIVE SAME TREATMENT Receives: Drug: Sodium Tetradecyl Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain by VAS score
pain by VAS score
Measured: 1 MONTH
leg edema
leg edema
Measured: 1 MONTH
cosmesis
cosmesis
Measured: 1 MONTH
cost effectiveness
cost effectiveness
Measured: 1 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start21 Feb 2020
- Primary completion21 Feb 2021 (estimated)
- Study completion21 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anum Arif, Combined Military Hospital, Pakistan
- Investigators
- Anum Arif, Principal investigator, Combined military hospital lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655417
- Sponsor's protocol ID
- CMHL
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- is Ultrasound-guided Foam Sclerotherapy a Cost-effective Alternate for Treatment of Varicose Veins?
- ClinicalTrials.gov ID
- NCT04655417
- Acronym / sponsor ID
- CMHL
- Conditions
- Pain, Leg Edema, Cost Effectiveness, Cosmesis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Combined Military Hospital, PakistanUniversity, hospital or other
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 21 Feb 2021 (estimated)
- Study completion
- 21 Feb 2021 (estimated)
- First posted
- 7 Dec 2020 (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.
. It is the aim of this paper is to discuss our experience of foam sclerotherapy for varicose veins atour hospital
Detailed description
we will manage all patients with vericose veins with injection sclerotherapy and will monitor there response in terms of relive in vsisble veins, swelling and pain.
we also want to evaluate hoe many sessions of injection sclerotherapy are required for complete resolution of symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION GROUP | Experimental | Drug: Sodium Tetradecyl SulfateSINGLE ARM OF PATIENTS WHO WILL RECEIVE SAME TREATMENT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All the patients who present with symptomatic varicose veins underwent a duplex scan by radiologist to identify site of reflux and condition of deep veins. If the patient is a candidate for intervention then he is offered surgery or foam sclerotherapy
Key exclusion criteria (1 listed)
- recurrent and secondary varicose veins
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 |
|---|---|---|
| Sodium Tetradecyl SulfateAlso: STSDRUG WILL BE INJECTED TO ALLAPTIENTS ACCORDING TO STANDARD PROTOCOL | Drug | INTERVENTION GROUP |
Primary outcome
pain by VAS score
Time frame: 1 MONTH
pain by VAS score
leg edema
Time frame: 1 MONTH
leg edema
cosmesis
Time frame: 1 MONTH
cosmesis
cost effectiveness
Time frame: 1 MONTH
cost effectiveness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Anum Arif principal investigator
Combined military hospital lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sodium Tetradecyl Sulfate in people with Pain and Leg Edema, run by Combined Military Hospital, Pakistan at 1 site in Pakistan.
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 1 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: status not confirmed, as of the sponsor's last update on 7 Dec 2020. 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 Pakistan. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anum Arif, MBBS FCPS (+923422398424, dranumarif@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain by VAS score (time frame: 1 MONTH). The study lists 4 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 7 Dec 2020.