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A single-center, prospective cohort to evaluate the efficacy of DIAFORA system in prognosis evaluation of Chinese diabetic foot patients

A single-center, prospective cohort to evaluate the efficacy of DIAFORA system in prognosis evaluation of Chinese diabetic foot patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500110072
Enrollment
Unknown
Registered
2025-09-29
Start date
2025-09-29
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Diabetic foot

Interventions

Patients with diabetic foot:None

Sponsors

Air Force Hospital of Northern Theater Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Signed written informed consent form (Informed Consent Form, ICF); 2. Age >= 18 years, either gender; 3. Clinically diagnosed with type 1 or type 2 diabetes mellitus and presence of at least one skin ulcer below the ankle (diabetic foot); 4. The target ulcer has been present for less than 6 weeks prior to enrollment; 5. Good compliance, with willingness and ability to fully adhere to the follow-up requirements of this study protocol.

Exclusion criteria

Exclusion criteria: 1. Incomplete medical records; 2. Amputation due to trauma in diabetic patients; 3. Incomplete follow-up until healing, amputation, or death, or follow-up duration less than 3 months; 4. Suspected malignancy at the ulcer site based on clinical assessment by the investigator; 5. Unhealed wound following amputation; 6. Pressure ulcer.

Design outcomes

Primary

MeasureTime frame
Major amputation;

Secondary

MeasureTime frame
Minor amputation;Healing;Death;

Countries

China

Contacts

Public ContactWu Yanxiang

Air Force Hospital of Northern Theater Command

wuyanxiang463@sina.com+86 133 2244 5900

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026