A study of the benefit of fat transfer to the peri-oral area for scleroderma patients

Feasibility study of stem-cell enriched autologous lipotransfer to treat oro-facial fibrosis in systemic sclerosis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17793055

Enrollment

Registered

2019-09-10

Start date

2019-10-01

Completion date

Unknown

Last updated

2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioral fibrosis of systemic sclerosis (scleroderma) Musculoskeletal Diseases Perioral fibrosis of systemic sclerosis (scleroderma)

Interventions

Sys-Stem is a single centre trial that will take place at the Royal Free London NHS Foundation Trust directly assessing feasibility for the main multi-centre trial. Sys-Stem is an ope

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >18 < 90 years 2. Limited or diffused forms of systemic sclerosis in the established phase of the disease 3. Clinically relevant impact on facial function 4. Willing and able to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Body mass index <18.5 2. Pregnant 3. Not fit for a general anaesthetic as per heart and lung function. 4. Any active infection which precludes fat harvest or injection

Design outcomes

Primary

Measure	Time frame
The Mouth Handicap in Systemic Sclerosis Scale (MHISS) to measure the outcome of autologous fat transfer for treating perioral fibrosis of systemic sclerosis, measured at each visit then post-intervention at 6 weeks, 3 months and 6 months	—

Secondary

Measure	Time frame
Feasibility of running a full trial: 1. Estimate recruitment rate required for the main trial. 2. Estimate attrition rate required for main trial. 3. Willingness of participants to be randomised 4. Feasibility of obtaining patient-reported outcomes via psychological and quality of life questionnaires; Visual Analogue Scale (VAS) Derriford Appearance Scale (DAS24), Brief Fear of Negative Evaluation Scale (BFNE), Hospital Anxiety and Depression Scale (HADS), EuroQol (EQ-5D-5L) 5. Feasibility of determining cost-effectiveness in main trial, by quality-adjusted life-years calculated from the EQ-5D-5L, and costs to the NHS according to health care service use questionnaires. 6. Acceptability of a range of qualitative and quantitative outcome measures (inter dental and mouth aperture measurements, cutometry, durometry, thermography, ultrasound, handheld visual capillary microscope (HVC).	—

Measure

Time frame

Feasibility of running a full trial: 1. Estimate recruitment rate required for the main trial. 2. Estimate attrition rate required for main trial. 3. Willingness of participants to be randomised 4. Feasibility of obtaining patient-reported outcomes via psychological and quality of life questionnaires; Visual Analogue Scale (VAS) Derriford Appearance Scale (DAS24), Brief Fear of Negative Evaluation Scale (BFNE), Hospital Anxiety and Depression Scale (HADS), EuroQol (EQ-5D-5L) 5. Feasibility of determining cost-effectiveness in main trial, by quality-adjusted life-years calculated from the EQ-5D-5L, and costs to the NHS according to health care service use questionnaires. 6. Acceptability of a range of qualitative and quantitative outcome measures (inter dental and mouth aperture measurements, cutometry, durometry, thermography, ultrasound, handheld visual capillary microscope (HVC).

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Countries

United Kingdom

Contacts

Public ContactCarole Frosdick

carole.frosdick1@nhs.net+442037582000 ex 36918

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026