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AzTrials

Diabetic Foot UlcerPhase 2NCT00393510

Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers

A Phase 2 study testing TCM in people with Diabetic Foot Ulcer and Amputation, run by Chinese University of Hong Kong at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Chronic foot ulcers occurring among diabetic patients are difficult to heal. The frequent elderly age with co-morbidities, vascular insufficiencies, peripheral neuropathies and super imposed infections, all contribute towards the chronicity and failure of treatment. Preserving the ulcerated limb is the patients' wish. Read more about this study

Who is it for?
Any age
Conditions the study is for
Diabetic Foot Ulcer, Amputation
What is being tested?
TCM
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
2 sitesChina
Study dates
Nov 2000to Mar 2006
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Well Controlled diabetic state
  • Presence of gangrene or non-healing ulcer in diabetic patients over the foot or feet. Infection should be well controlled.
  • Good glycaemic control

Who cannot join

  • Pregnant women and women at risk of conception
  • Patients taking digitalis glycosides
  • Patients with abnormal liver function tests
  • Patients with plasma creatinine great then 150 umol/l or unstable renal function
  • Poorly controlled Diabetes Mellitus
  • Uncontrolled infection
Show all 9Show fewer
  • History of adverse reaction to herbal medicine
  • Unstable medical conditions
  • Non-compliance with regime

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Department of Orthopaedics & Traumatology, Prince of Wales hospital

    Hong Kong

  • Department of Orthopaedics and Traumatology, Kwong Wah Hospital

    Hong Kong

Other trials in China

About this study

Official title: An Evidence Base Study on the Clinical Effects of Integrated Western Medicine and Traditional Chinese Medicine for Diabetic Foot Ulcer Treatment

Chronic foot ulcers occurring among diabetic patients are difficult to heal. The frequent elderly age with co-morbidities, vascular insufficiencies, peripheral neuropathies and super imposed infections, all contribute towards the chronicity and failure of treatment. Preserving the ulcerated limb is the patients' wish. On the other hand, an infected ulcer that never heals just unnecessarily prolongs suffering. Nevertheless, patients earnestly like to try all methods of healing before accepting amputation.

Objective:To determine whether a course of herbal preparation used as an adjuvant therapy for diabetic patients suffering from chronic foot ulcers may promote healing so that major leg amputation can be avoided.

Being tested
TCM, Placebo
Keywords
Diabetic Foot Ulcer, Traditional Chinese Medicine
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TCMDrug

    The Decoction is taken orally, twice a day, treatment period is 24 weeks The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients.

    The formula consisted of 12 herbs, viz:

    Radix astragali, Rhizoma atractylodis marcocephalae, Radix stephaniae tetrandrae, Radix polygoni multiflori, Radix rehmanniae, Radix smilax china, Fructus corni, Rhizoma dioscoreae, Cortex moutan, Rhizoma alismatis, Rhizoma smilacis glabrae, and Fructus schisandrae

  • PlaceboDrug

    Placebo taking orally, twice a day, 24 week treatment period The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients.

    The placebo was made with starch and colouring materials.

Study groups in NCT00393510
Study groupRoleWhat they receive
Traditional Chinese MedicineActive comparator12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
Receives: Drug: TCM
PlaceboPlacebo comparatorPlacebo was made with starch and colouring materials. Given to patient orally twice a day
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Limb Salvage

    The number of successful limb rescued (without amputation).

    Measured: 24 weeks

Secondary outcomes (2)

  1. Tumour Necrosis Factor-alpha Levels in Serum

    The state of inflammation at baseline and at 4 weeks after treatment. TNF-alpha are in value of serum level.

    Measured: Baseline and 4 week

  2. Time of Ulcer Healing

    Time taken for maturation of granulation to enable skin grafting.

    Measured: 24 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2006 (estimated)
  2. Study startNov 2000
  3. Primary completionMar 2006
  4. Study completionMar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00393510
Sponsor's protocol ID
CRE-8342
Status last verified
Jul 2010
First submitted
26 Oct 2006
Last updated
13 Jul 2010
Data monitoring committee
No

Publications

  • Levin ME. Diabetic foot ulcers: pathogenesis and management. J ET Nurs. 1993 Sep-Oct;20(5):191-8.

    PubMed 8110884

  • Nelzen O, Bergqvist D, Lindhagen A. High prevalence of diabetes in chronic leg ulcer patients: a cross-sectional population study. Diabet Med. 1993 May;10(4):345-50. doi: 10.1111/j.1464-5491.1993.tb00077.x.

    PubMed 8508618

  • Steed DL, Goslen JB, Holloway GA, Malone JM, Bunt TJ, Webster MW. Randomized prospective double-blind trial in healing chronic diabetic foot ulcers. CT-102 activated platelet supernatant, topical versus placebo. Diabetes Care. 1992 Nov;15(11):1598-604. doi: 10.2337/diacare.15.11.1598.

    PubMed 1468291

  • Ahlgren SC, Levine JD. Protein kinase C inhibitors decrease hyperalgesia and C-fiber hyperexcitability in the streptozotocin-diabetic rat. J Neurophysiol. 1994 Aug;72(2):684-92. doi: 10.1152/jn.1994.72.2.684.

    PubMed 7983528

  • Bazan NG, Gordon WC, Marcheselli VL, Lukiw WJ, Duhault J, Koenig-Berard E, Linn DM, DeCoster MA, Mukherjee PK. Experimental models and their use in studies of diabetic retinal microangiopathy. Therapie. 1997 Sep-Oct;52(5):447-51.

    PubMed 9501573

  • Diemel LT, Brewster WJ, Fernyhough P, Tomlinson DR. Expression of neuropeptides in experimental diabetes; effects of treatment with nerve growth factor or brain-derived neurotrophic factor. Brain Res Mol Brain Res. 1994 Jan;21(1-2):171-5. doi: 10.1016/0169-328x(94)90391-3.

    PubMed 7513041

  • Follansbee MH, Beyer KH Jr, Griffith JW, Vesell ES. Studies on pyrazinoylguanidine. 5. Temporal effects over 24 weeks demonstrating attenuation of diabetic nephropathy in STZ-diabetic rats. Pharmacology. 1997 May;54(5):241-55. doi: 10.1159/000139492.

    PubMed 9380770

  • Kunjathoor VV, Wilson DL, LeBoeuf RC. Increased atherosclerosis in streptozotocin-induced diabetic mice. J Clin Invest. 1996 Apr 1;97(7):1767-73. doi: 10.1172/JCI118604.

    PubMed 8601643

  • Liu S, Barac-Nieto M. Renal protein degradation in streptozotocin diabetic mice. Diabetes Res Clin Pract. 1997 Jan;34(3):143-8. doi: 10.1016/s0168-8227(96)01353-8.

    PubMed 9069565

  • Mavrikakis ME, Sfikakis PP, Kontoyannis D, Horti M, Kittas C, Koutras DA, Raptis SA. Macrovascular disease of coronaries and cerebral arteries in streptozotocin-induced diabetic rats. A controlled, comparative study. Exp Clin Endocrinol Diabetes. 1998;106(1):35-40. doi: 10.1055/s-0029-1211947.

    PubMed 9516057

  • Zochodne DW, Murray MM, van der Sloot P, Riopelle RJ. Distal tibial mononeuropathy in diabetic and nondiabetic rats reared on wire cages: an experimental entrapment neuropathy. Brain Res. 1995 Nov 6;698(1-2):130-6. doi: 10.1016/0006-8993(95)00876-r.

    PubMed 8581471

  • Wagner EW. Classification of neuropathic foot problems AAOS instructional lecture 28 St. Louis Mosby 1979 p143-165

  • Brodsky JW. Diabetic Foot Surgery of Foot and Ankle. St. louis Mosby 1992, p1361-1467

  • Conn, H.M., M.A. and Emmel, V.M. Staining Procedures. Williams and Wilkins Co., Baltimore, 289 pp.m (1960)

  • Professor P.C. Leung. Limb Salvage for Diabetic ulceration with Traditional Chinese Techniques. Pacific, BioTech News. Vol.1 No.31 1998, Singapore

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TCM in people with Diabetic Foot Ulcer and Amputation, run by Chinese University of Hong Kong at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Limb Salvage (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00393510, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2010.

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