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Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01898923
Recruitment Status : Completed
First Posted : July 15, 2013
Results First Posted : April 14, 2021
Last Update Posted : April 14, 2021
Information provided by (Responsible Party):
Oneness Biotech Co., Ltd.

Brief Summary:
The primary objective of this study is to evaluate the efficacy of the new treatment of WH-1 ointment compared to Aquacel® Hydrofiber® dressing, applied to chronic diabetic foot ulcers for up to 16 weeks.An additional objective of this study is to collect safety information including adverse events and clinical laboratory abnormalities.

Condition or disease Intervention/treatment Phase
Diabetic Foot Drug: ON101 Cream Other: Aquacel® Hydrofiber® dressing Phase 3

Detailed Description:

This trial is designed as a randomized, evaluator blinded, active-controlled, multi-center study comparing the efficacy and safety of WH-1 ointment and Aquacel® Hydrofiber® dressing in the treatment of diabetic foot ulcers. Independent evaluators who blinded to subjects' treatment will evaluate whether the wound has healed. Eligible subjects will be randomized to receive either WH-1 ointment or Aquacel® Hydrofiber® dressing in a 1:1 allocation. The study treatment will be applied to the selected ulcer for a maximum period of 16 weeks, until the wound/ulcer closure (wound size of 0) for two consecutive visits at least 2 weeks apart, or until the subject exited the study as treatment failure. After that, all subjects regardless of wound healing at the end of comparison period will be followed for 12 weeks to investigate durability. During the follow-up period, Aquacel® Hydrofiber® dressing will be applied for subjects who have unhealed or with recurrent wound. Each target ulcer with wound photographs for blind assessment will be monitored at each scheduled visit.

One interim analysis is planned at around 50% of study information; the final analysis will be conducted at the end of the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study to Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
Actual Study Start Date : November 23, 2012
Actual Primary Completion Date : May 11, 2020
Actual Study Completion Date : May 11, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ON101 Cream
ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks.
Drug: ON101 Cream
Other Name: WH-1

Aquacel® Hydrofiber® dressing
Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days.
Other: Aquacel® Hydrofiber® dressing

Primary Outcome Measures :
  1. Number of Participants With Complete Ulcer Closure [ Time Frame: 16 weeks ]

    The primary variable is the number of target ulcers healed in each group within 16 weeks. The primary efficacy outcome is the comparison of the incidence of complete healing of the target ulcer between the two treatment groups at the end of treatment.

    For the purpose of this study a complete healing will be defined as complete epithelialization which is maintained with no drainage for at least 2 weeks and is confirmed by a blinded assessor.

Secondary Outcome Measures :
  1. The Time of Healing Rate [ Time Frame: 16 weeks ]
    Time to complete ulcer healing, The time of the original healing will be taken as the time to healing.

  2. Change in Ulcer Area [ Time Frame: 16 weeks ]
    Percentage change in ulcer surface area from baseline

  3. Percentage of Participants With a 50% Reduction of Ulcer Surface Area [ Time Frame: 16 weeks ]
    Percentage of subjects with a 50% reduction of ulcer surface area

  4. Incidence of Infection of the Target Ulcer [ Time Frame: 16 weeks ]
    Incidence of infection of the target ulcer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Has signed a written informed consent prior to the first study evaluation;
  2. Male or female is at least 20 and < 80 years of age;
  3. Diabetes mellitus (type 1 or 2) with an HbA1c < 12.0% measured during screening or within three months prior to randomization;
  4. An ankle brachial index on the target limb at least 0.8 measured during screening or within three months prior to randomization;
  5. The target ulcer must have the following characteristics:

    • Grade 1 or 2 per Wagner Ulcer Classification System;
    • No higher than the ankle;
    • No active infected;
    • A cross-sectional area of between 1 and 25 cm2 post-debridement;
    • Present for at least 4 weeks before randomization;
  6. If female and of childbearing potential has a negative pregnancy test and is not breastfeeding at screening visit;
  7. Able and willing to attend the scheduled visits and comply with study procedures.

Exclusion Criteria:

  1. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement;
  2. Acute Charcot's neuroarthropathy as determined by clinical and/or radiographic examination;
  3. Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to randomization;
  4. Poor nutritional status defined as an albumin < 2.5 g/dL;
  5. Aspartate Aminotransferase(AST, GOT) and/or Alanine Aminotransferase(ALT, GPT) >3 x the normal upper limit;
  6. Serum Creatinine >2 x the normal upper limit;
  7. Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 4 weeks before randomization;
  8. Use of any investigational drug or therapy within the 4 weeks prior to randomization;
  9. A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject's medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance;
  10. Judged by the investigator not to be suitable for the study for any other reason.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01898923

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Sponsors and Collaborators
Oneness Biotech Co., Ltd.
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Study Director: Henry Chang Oneness Biotech
  Study Documents (Full-Text)

Documents provided by Oneness Biotech Co., Ltd.:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Oneness Biotech Co., Ltd. Identifier: NCT01898923    
Other Study ID Numbers: ON101CLCT02
First Posted: July 15, 2013    Key Record Dates
Results First Posted: April 14, 2021
Last Update Posted: April 14, 2021
Last Verified: March 2021
Keywords provided by Oneness Biotech Co., Ltd.:
WH-1,Diabetic Foot,Ulcer
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Carboxymethylcellulose Sodium
Gastrointestinal Agents