Evaluate the Efficacy and Safety of WH-1 Ointment for the Treatment of Chronic Diabetic Foot Ulcers

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Oneness Biotech Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Oneness Biotech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01898923
First received: July 8, 2013
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Diabetic Foot
Drug: WH-1 ointment
Other: Aquacel® Hydrofiber® dressing
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study to Evaluate the Efficacy and Safety of WH-1 Ointment for the Treatment of Chronic Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by Oneness Biotech Co., Ltd.:

Primary Outcome Measures:
  • The incidence of complete ulcer closure [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

    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:
  • The time of healing rate [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Time to complete ulcer healing, The time of the original healing will be taken as the time to healing.

  • change in ulcer area [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Percentage change in ulcer surface area from baseline

  • 50% reduction in ulcer area [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Percentage of subjects with a 50% reduction of ulcer surface area

  • Incidence of infection of the target ulcer [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Incidence of infection of the target ulcer


Estimated Enrollment: 212
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WH-1 ointment
WH-1 ointment(1.25%),15g ointment per tube. Twice daily for up to 16 weeks.
Drug: WH-1 ointment
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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-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 neither breastfeeding or intending to become pregnant during the study;
  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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898923

Contacts
Contact: Rita Lai +886-2-26558098 ext 320 rita.lai@onenessbio.com.tw
Contact: Roger Lin +886-2-26558098 ext 315 roger.lin@onenessbio.com.tw

Locations
Taiwan
Clinical Research Division Recruiting
Taipei, Taiwan, 115
Contact: Rita Lai, Director    +886-2-26558098 ext 320    rita.lai@onenessbio.com.tw   
Contact: Roger Lin, Associate Project Manager    +886-2-26558098 ext 315    roger.lin@onenessbio.com.tw   
Principal Investigator: Yuan-Sung Kuo, M.D.         
Principal Investigator: Kwang-Yi Tung, M.D.         
Principal Investigator: Shyi-Gen Chen, M.D.         
Principal Investigator: Hsuan-Li Huang, M.D.         
Principal Investigator: Yu-Yao Huang, PhD., M.D.         
Sub-Investigator: Hsin-Han Chen, M.D.         
Sub-Investigator: Yung-Chang Hsu, M.D.         
Sub-Investigator: Tzong-Shiun Li, M.D.         
Sub-Investigator: Ching-Chu Chen, M.D.         
Sub-Investigator: Rong-Hsing Chen, M.D.         
Sub-Investigator: Tzu-Yuan Wang, M.D.         
Sub-Investigator: Hsiung-Fei Chien, M.D.         
Sub-Investigator: Shih-Hsin Chang, M.D.         
Sub-Investigator: Chia-Meng Yu, M.D.         
Sub-Investigator: Tsung-Sheng Ni, M.D.         
Sub-Investigator: Shun-Cheng Chang, M.D.         
Sub-Investigator: Tim-Mo Chen, M.D.         
Sub-Investigator: Niann-Tzyy Dai, M.D.         
Sub-Investigator: Shou-Cheng Teng, M.D.         
Sub-Investigator: Yuan-Sheng Tzeng, M.D.         
Sub-Investigator: Chih-Hsin Wang, M.D.         
Sub-Investigator: Cheng-Jyh Lin, M.D.         
Sub-Investigator: Hsin-Hua Chou, M.D.         
Sub-Investigator: Shuo-Suei Hung, M.D.         
Sub-Investigator: Tien-Yu Wu, M.D.         
Sub-Investigator: Chung-Huei Huang, M.D.         
Sub-Investigator: Cheng-Wei Lin, M.D.         
Sub-Investigator: Chih-Ching Wang, M.D.         
Sub-Investigator: Ray-Houng Sun, M.D.         
Sub-Investigator: Chih-Yiu Tsai, M.D.         
Sub-Investigator: Jiun-Ting Yeh, M.D.         
Sub-Investigator: Hui-Mei Yang, Nurse Practitioner         
Sponsors and Collaborators
Oneness Biotech Co., Ltd.
Investigators
Principal Investigator: Wu Chao-I China Medical University Hospital
  More Information

No publications provided

Responsible Party: Oneness Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01898923     History of Changes
Other Study ID Numbers: ON101CLCT02
Study First Received: July 8, 2013
Last Updated: July 25, 2014
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Oneness Biotech Co., Ltd.:
WH-1,Diabetic Foot,Ulcer

Additional relevant MeSH terms:
Diabetic Foot
Ulcer
Foot Ulcer
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on August 26, 2014