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A study of Fructose-1,6-Diphosphate for the treatment of Systemic Sclerosis

The mechanism of Fructose-1,6-Diphosphate in regulating fibroblast activity and ameliorating disease progression in Systemic Sclerosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123627
Enrollment
Unknown
Registered
2026-04-28
Start date
2025-12-10
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Systemic sclerosis

Interventions

Non-Systemic sclerosis group:None

Sponsors

The First Affiliated Hospital of the Baotou Medical College of Inner Mongolia University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria for the systemic sclerosis patient group: 1. Meet the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for systemic sclerosis (SSc); 2. Disease severity is mild to moderate (with an appropriate modified Rodnan skin score (mRSS) range and no severe internal organ involvement); 3. No use of glucocorticoids, disease-modifying antirheumatic drugs (DMARDs), biologics, or other immunosuppressive therapies within three months; 4. Subjects fully understand the study rationale and objectives, voluntarily participate in this study, and sign a written informed consent form. Inclusion criteria for the non-systemic sclerosis patient group: 1. Aged 18 to 70 years; 2. No history of autoimmune diseases; 3. No severe skin diseases; 4. Voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria for the systemic sclerosis patient group: 1. Concurrent other autoimmune or rheumatic diseases (such as systemic lupus erythematosus, rheumatoid arthritis, dermatomyositis, etc.) or conditions that cannot be clearly distinguished from SSc; 2. Presence of active infection, pulmonary arterial hypertension, severe cardiac, hepatic, or renal insufficiency (based on laboratory tests and clinical evaluation), or a history of malignancy; 3. Women who are pregnant or lactating, or women of childbearing age who have not adopted effective contraceptive measures; 4. Any other condition that may interfere with study assessments, affect subject safety or compliance (such as psychiatric disorders, history of substance abuse), or at the investigator's discretion, deems the subject unsuitable for participation in this study. Exclusion criteria for the non-systemic sclerosis patient group: 1. Presence of conditions that cannot be clearly distinguished from systemic sclerosis; 2. Presence of active infection, pulmonary arterial hypertension, severe cardiac, hepatic, or renal insufficiency (based on laboratory tests and clinical evaluation), or a history of malignancy; 3. Any other condition that may interfere with study assessments, affect subject safety or compliance (such as psychiatric disorders, history of substance abuse), or at the investigator’s discretion, deems the subject unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
The metabolic characteristics of SSc skin tissue;

Secondary

MeasureTime frame
The extent of fibrosis in skin tissue.;Basic information such as the subject’s gender, age, medical history, medication history, etc.;The expression levels of TGF-ß1, p-Smad2/3, Smad7, a-SMA, and Col I in skin tissue;

Countries

China

Contacts

Public ContactYongfu Wang

The First Affiliated Hospital of the Baotou Medical College of Inner Mongolia University of Science and Technology

wyf18686198868@163.com+86 472 2178780

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026