Condition category
Circulatory System
Date applied
15/04/2004
Date assigned
21/04/2004
Last edited
13/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Samir Afify

ORCID ID

Contact details

Watson Suite
Rochdale Infirmary
Whitehall Street
Rochdale
OL12 0NB
United Kingdom
+44 1706 517113
mr.afify@pat.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The Role of Thrombophilia in the Management of Patients with venous Leg Ulcers

Acronym

RTMPLU

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Venous Leg Ulcers

Intervention

Intervention: Folic Acid supplementation of 5 mg/day for 6 months + standard care
Control: Placebo + standard care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2000

Overall trial end date

31/05/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Patients suffering from venous leg ulcers, who are thrombophilia positive

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2000

Recruitment end date

31/05/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Watson Suite
Rochdale
OL12 0NB
United Kingdom

Sponsor information

Organisation

Pennine Acute Hospitals NHS Trust

Sponsor details

The Director of Research and Development
Royal Oldham Hospital
Rochdale Road
Oldham
OL1 2JH
United Kingdom
+44 160 6240420
deepak.bhatnagar@pat.nhs.uk

Sponsor type

Not defined

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Research and Development Department, Royal Oldham Hospital, Oldham

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

13/09/2016: No publications found in PubMed, verifying study status with principal investigator.