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Completed

NCT Number: NCT05135130

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

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.

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Key information

Conditions

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

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

China Medical University Hospital

Taichung, 404, Taiwan

About this study

This ClinicalTrials.gov record exists that reports results for the ON101CLCT02 trial.(identifier: NCT01898923)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

No additional inclusion or exclusion criteria will be applied.

Treatment and study plan

ON101 Cream

Drug

Not applicable in this retrospective study

Primary outcomes

  1. Demographic Characteristics: Weight (Mean)

    Time frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.

  2. Demographic Characteristics: BP (Mean)

    Time frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.

  3. Demographic Characteristics: ABI (Mean)

    Time frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.

    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.

  4. Medical Costs Due to DFUs

    Time frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.

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

  5. Percentage of Amputation

    Time frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.

    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.

Sponsors and collaborators

Lead sponsor

Oneness Biotech Co., Ltd.

Industry

Registry information

Official study title

A Retrospective Record-review Study in Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 26, 2021
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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