An investigator-initiated exploratory clinical trial for refractory skin ulcer of lower leg using silk-elastin sponge (P47K-WAS) to evaluate the safety

An investigator-initiated exploratory clinical trial for refractory skin ulcer of lower leg using silk-elastin sponge (P47K-WAS) to evaluate the safety - An exploratory clinical trial for refractory skin ulcer of lower leg using silk-elastin sponge (ECRUS)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030694

Enrollment

Registered

2018-01-05

Start date

2018-03-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Refractory skin ulcer of lower leg

Interventions

Sponge containing 12.5 mg/cm2 silk-elastin will be administered once and be kept for 14 days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Four-week healing rate is under 50%. 2)An ulcer under knee joint. 3)An ulcer area is between 2 and 25 cm2. 4)An ulcer covered by an investigational device is able to be sealed with polyurethane film. 5)No other ulcers within 5 cm around the ulcer. 6)No local infection of the ulcer. 7)Bone exposure area is under 10% of the ulcer area. 8)Skin perfusion pressure of the affected leg is 30 mmHg or more.

Exclusion criteria

Exclusion criteria: 1)Patients are ages under 20 when they consent to participate in this trial. 2)Women who are or may be pregnant. Women who are nursing. Women who do not consent to use contraception during this trial. 3)Patients with previous histories of allergy for silk, urethane, and the reagent used in this trial, such as local anesthetics and disinfectant. 4)Patients with any of the following conditions: *Poorly controlled diabetes (>=10% of HbA1c in latest laboratory findings within 28 days before enrollment). *Patients recieving hemodialysis or peritonial dialysis. *Patients being treated of malignancy. *Patients requiring continuous systemic administration of steroids (a dose exceeding an equivalent predonisolone dose of 10 mg/day). 5)Patients who have participated in another clinical trial within 3 months before enrollment. 6)Patients who have participated in this trial and administered with an investigational device. 7)Patients are not able to provide consent to participate in this trial in writing. 8)Other individuals whom an investigator or sub-investigator deems inappropriate for participation in this trial.

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events and reactions	—

Secondary

Measure	Time frame
1. The occupancy of granulation tissue 2. The rate of ulcer area reduction 3. Incidence of clinical observation for local infection 4. The rate for completion of 7 and 14 days after overlaying silk-elastin sponge	—

Countries

Japan

Contacts

Public ContactKazuo Noda

Kyoto University Hospital Department of Plastic and Reconstructive Surgery

ecrus_office@kuhp.kyoto-u.ac.jp+81-75-751-3613

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026