Retrospective Record-review Study in Patients Who Had Diabetic Foot Ulcer

NCT05135130 | Completed Results

• 1 other identifier: ON101CLOS01
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the medical cost of illness for DFUs on the patients who had used ON101 or Aquacel® in the ON101CLCT02 trial.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (5)

• Demographic Characteristics: Weight (Mean)

  Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.

• Demographic Characteristics: BP (Mean)

  Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.

• Demographic Characteristics: ABI (Mean)

  Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. The normal range for the ankle-brachial index is between 0.90 and 1.30. An index of 0.41 to 0.90 indicates mild to moderate arterial disease and an index of 0.40 and lower indicates severe disease. An index higher than 1.3 indicates stiff, non-compressible blood vessels which are common in diabetes. Left and right Ankle-Brachial Index (ABI) values are calculated by dividing the highest systolic pressure from each ankle (posterior tibial or dorsalis pedis artery) by the highest overall brachial (arm) systolic pressure.

  Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.

• Medical Costs Due to DFUs

  The total medical cost due to diabetic foot ulcers across 140 participants is reported.

  Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.

• Percentage of Amputation

  Major amputations involve removing a limb above or through the ankle (e.g., below-knee/transtibial, above-knee/transfemoral), significantly impacting mobility. Minor amputations, such as toes or metatarsal, are distal to the ankle and aim to preserve function. Total amputations include the sum of major and minor amputations.

  Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.

Study Arms (2)

ON101 Cream

Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to ON101 Cream arm

Drug: ON101 Cream

Aquacel® Hydrofiber® dressing

Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial and assigned to Aquacel® Hydrofiber® dressing arm

Interventions

ON101 Cream DRUG

Not applicable in this retrospective study

ON101 Cream

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The ON101CLCT02 trial enrolled 236 subjects and was conducted in Taiwan, China, and USA. The target population of this study consists of the Taiwanese DFU patients who had completed or early withdrawn from the ON101CLCT02 trial.

Sponsors & Collaborators

• Oneness Biotech Co., Ltd.: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Jessica Ho
• Organization: Oneness Biotech Co., Ltd.

jesssica.ho@onenessbio.com.tw

+886 2703 1098

Study Officials

• Shyi-Gen Chen, MD

  Oneness Biotech Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 26, 2021
• Study Start: October 4, 2021
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: March 6, 2026
• Results First Posted: March 6, 2026

Record last verified: 2026-02

Locations

TW (1)